{"schema":"sb.node.v1","id":"sb:e/40dffb88e8e0c4930d1699ca","kind":"entity","label":{"text":"cdrh","locale":"en"},"identity":{"anchor":"label:en:cdrh","strength":"label"},"asOf":{"knowledgeCutoff":"2026-10-10T23:27:45.667496+00:00","snapshot":"deploy ca5d81785b2e8e9d3cb25b959dbaa72ddee4391e"},"lens":{"kind":"public"},"build":{"plane":"projected","builtFrom":["entity_graph.slim.json","entity_receipts (deploy asset)","event_graph.json","truth_records (deploy asset)","corroborated_record.json"],"rule":"node-projection.entity@v1"},"standing":{"evidence":{"supporting":19,"separatePublishers":3,"basis":"documents that mention the subject and the outlets that carried them; a mention is evidence the referent is in use, not evidence about any claim","receiptsOnTopic":{"state":"partial","share":0.211,"named":4,"of":19,"basis":"documents whose own title or summary lead names the subject, over every counted document that mentions it anywhere (the entity graph's measurement); receipts are drawn from the former only","blind":["only 21% of the 19 documents measured name the subject in their own text; the rest mention it in passing, so standing.evidence.supporting overstates coverage about it"]}},"admission":{"state":"provisional","reason":"entity graph provenance 'observed'; the node carries no promotion receipt in v1","policy":"EQ-PROMOTION (receipt not carried)"},"disposition":{"state":"served","reason":"public record"},"validity":{"from":"2026-09-03","to":"2026-10-08","basis":"first and last day we saw it mentioned; not the subject's own lifetime"},"measurement":{"state":"partial","blind":["assertion coverage 0.211: about 79% of mentions carry no typed assertion"]}},"dimensions":{"domains":["fda_decisions","biotech_pharma"],"activeDays":15,"assertions":{"regulatory-approval":4}},"up":[],"upNote":"An entity is a root: it is contained by nothing. Pan out by following R.","children":{"count":4,"byKind":{"observation":4},"items":[{"id":"sb:o/abdc13ee553c467883e34d0d","kind":"observation","label":"FDA · 2026-09-30 · Study Data Standards Resources","url":"http://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources"},{"id":"sb:o/16cab86dde3dbde6918cdb1b","kind":"observation","label":"FDA · 2026-09-24 · Early Alert: Ventilator Issue from React Health","url":"http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-ventilator-issue-react-health"},{"id":"sb:o/deec38d3032aaf61557943a6","kind":"observation","label":"FDA · 2026-09-24 · Early Alert: Heart Pump Controller Issue from Abiomed","url":"http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-controller-issue-abiomed"},{"id":"sb:o/27445d9dade73c47833acfeb","kind":"observation","label":"FDA · 2026-09-04 · Early Alert: Breathing Circuit Issue from Draeger","url":"http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-breathing-circuit-issue-draeger"}],"cursor":null,"order":"newest first; we keep the 4 newest receipts for this entity whose own title or summary lead (the entity graph's test) names it. Its other observations are counted in standing.evidence.supporting but are not addressable in v1"},"relations":{"count":4,"byKind":{"co-mentioned":4},"items":[{"kind":"relation","label":"co-mentioned with fda (19 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/30d1d391775eb0abb3a8c82b"},{"kind":"relation","label":"co-mentioned with cber (9 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/d54d4c8470beb8ec1c3c54ba"},{"kind":"relation","label":"co-mentioned with cder (8 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/d514dc71a9b5e0cd15c2502a"},{"kind":"relation","label":"co-mentioned with radiological health (8 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/9f349d65cf74bc51c0407a75"}],"cursor":null,"order":"situations first, then claims (the subject's own maintained record, then site-wide corroborated clusters; each label ends with its standing), then co-mentions by shared documents, descending. Co-mentions are the ten strongest the entity graph keeps per entity"},"edge":{"state":"continues"},"links":{"rest":"/api/v1/node/e/40dffb88e8e0c4930d1699ca","mcp":"traverse {\"id\":\"sb:e/40dffb88e8e0c4930d1699ca\"}","page":"/entity/cdrh/"},"limits":{"levelsPerCall":1,"pageSize":10,"maxPageSize":50,"membersMax":50,"statement":"One level per call: depth is 1 and only 1, and there is no whole-graph dump. pageSize 1-50 (default 10); a page limit is a cursor, never an edge. Members are listed up to 50. At most 60 traverse calls a minute per caller (runaway-loop protection, not a meter). One knowledge cutoff is served: the deploy's."},"actions":[{"verb":"unfold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/40dffb88e8e0c4930d1699ca\",\"level\":\"children\"}"},{"verb":"fold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/40dffb88e8e0c4930d1699ca\"}"},{"verb":"panOut","lit":false,"effect":"read","layer":"cantina","reason":"An entity is a root: it is contained by nothing. Pan out by following R."},{"verb":"follow","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/40dffb88e8e0c4930d1699ca\",\"level\":\"relations\"}"},{"verb":"receipts","lit":false,"effect":"read","layer":"cantina","reason":"receipts are the observations below this node; unfold to reach them"},{"verb":"edge","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/40dffb88e8e0c4930d1699ca\"}"},{"verb":"asOf","lit":false,"effect":"read","layer":"cantina","reason":"v1 serves one knowledge cutoff, this deploy's; walking an earlier cutoff needs retained history (EQ-REPLAY), which v1 does not keep"},{"verb":"switchObserver","lit":false,"effect":"read","layer":"cantina","reason":"the public record is the same for every observer; traversal through a Watch's lens is not served in v1"},{"verb":"readOriginal","lit":false,"effect":"read","layer":"cantina","reason":"no translation is applied on this node; every label is the source's own text"},{"verb":"save","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"saving applies to a configured Watch; configure one around this node first (free), then save it"},{"verb":"deliver","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"delivery applies to a saved Watch"},{"verb":"format","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"output format applies to a saved Watch"},{"verb":"deltaR","lit":false,"effect":"read","layer":"workshop","reason":"Delta R needs a saved Watch with a previous reading"},{"verb":"read","lit":false,"effect":"read","layer":"docking-bay","reason":"one-time Reads are parked until the Commander decides their shape (#938)"}]}