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

Carapace, Inc. — Predicate Candidate Screening

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

268 daysmedian FDA review time
321 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K931722CARAPACE LABOR AND DELIVERY SETSCarapace, Inc.1994-03-233500
K931822CARAPACE PELVIC EXAM TRAYSCarapace, Inc.1994-03-073330
K931729I.V. START KITCarapace, Inc.1994-02-223210
K931669CARAPACE DEBRIDEMENT KITSCarapace, Inc.1994-02-073070
K931820CARAPACE STILLWATER BOWL SETCarapace, Inc.1994-02-073050
K931760CARAPACE PACKING GAUZE TRAYSCarapace, Inc.1994-02-043020
K932653SWISSTEK 2000(TM) CAST REMOVAL SYSTEMCarapace, Inc.1994-01-282400
K931758CARAPACE WOUND DRESSING KITS & LACERATION TRAYSCarapace, Inc.1994-01-262930
K931819CARAPACE SUTURE REMOVAL TRAYSCarapace, Inc.1994-01-262930
K931670CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYSCarapace, Inc.1994-01-252940
K931759CARAPACE STERILE GAUZE TRAYSCarapace, Inc.1994-01-252920
K931673CARAPACE CATARACT TRAYSCarapace, Inc.1993-12-302680
K931672CARAPACE STERILE CAST PADDINGCarapace, Inc.1993-12-152530
K931629CARAPACE ANGIOGRAPHY TRAYSCarapace, Inc.1993-12-062480
K931824CARAPACE INSTRUMLENT AND INSTRUMENT SETSCarapace, Inc.1993-12-062420
K931626CARAPACE STERILE COTTON BALLSCarapace, Inc.1993-12-022440
K931597CARAPACE INCISION AND DRAINAGE TRAYSCarapace, Inc.1993-11-052180
K883294SYNTHETIC CAST TAPECarapace, Inc.1988-08-30260
K840976VARIOUS DISPOSABLE KITS/TRAYS/INSTRUCarapace, Inc.1984-05-31860
K813219CARAFLEX ELASTIC POLYMER PLASTER BANDACarapace, Inc.1981-12-17380
K790970SURGICAL FACE MASKCarapace, Inc.1979-07-03420
K782107LAP SPONGECarapace, Inc.1979-02-16590

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