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

Sierra Laboratories, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time
191 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.1997-04-22360
K962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERSierra Laboratories, Inc.1996-07-15250
K962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.1996-07-15240
K934266COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.1994-04-192310
K934052ALPINE REUSABLE LEG BAGSSierra Laboratories, Inc.1994-01-071410
K931156CONE CATHSierra Laboratories, Inc.1993-07-011140
K901000URO TEX URINALSSierra Laboratories, Inc.1990-03-26240
K883057COMFORT CATH MALE EXTERNAL CATHETERSierra Laboratories, Inc.1988-08-02140
K873039MODEL 820 TOP=TRAKSierra Laboratories, Inc.1988-02-111910
K832450URO-TEX MALE EXTERNAL CATHETERSierra Laboratories, Inc.1983-10-14800
K811887SKIN STAPLE EXTRACTORSierra Laboratories, Inc.1981-07-27260
K791410AMALGAMATOR MODEL SDC--Sierra Laboratories, Inc.1979-09-19690

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