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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Intramed Laboratories, Inc. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

110 daysmedian FDA review time
427 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953258TITANIUM HEMOSTATIC CLIPIntramed Laboratories, Inc.1996-01-051770
K942457GRAFT THROMBECTOMY INSTRUMENTSIntramed Laboratories, Inc.1995-02-072590
K931792ARTHROSCOPEIntramed Laboratories, Inc.1994-06-134270
K925283VALVULOTOMEIntramed Laboratories, Inc.1994-02-104780
K934696ANGIOSCOPEIntramed Laboratories, Inc.1994-01-181100
K922114ENDOSCOPIC RETRIEVAL BASKETIntramed Laboratories, Inc.1992-08-03900
K914385OPTICAL VALVULOTOMEIntramed Laboratories, Inc.1992-03-021530
K904465FLEXIBLE ARTHROSCOPEIntramed Laboratories, Inc.1990-12-20800
K903528LAPAROSCOPEIntramed Laboratories, Inc.1990-09-04290
K902444CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMPIntramed Laboratories, Inc.1990-08-30900
K901010FLEXIBLE CHOLEDOCHOSCOPEIntramed Laboratories, Inc.1990-05-22780
K894459ANGIOSCOPEIntramed Laboratories, Inc.1990-03-072320
K882761TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)Intramed Laboratories, Inc.1988-09-20760
K872282FLEXIBLE URETEROSCOPEIntramed Laboratories, Inc.1987-09-14900

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda