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

Surgical Technology Laboratories, Inc. · Predicate Candidate Screening

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

42 daysmedian FDA review time

81 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K170582	Saf-T-Vac Smoke and Fluid Evacuator	Surgical Technology Laboratories, Inc.	2017-04-14	45
K021889	SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)	Surgical Technology Laboratories, Inc.	2002-10-16	131
K983755	NASAL DORSAL SERIES	Surgical Technology Laboratories, Inc.	1998-11-20	29
K983754	STANDARD CHIN	Surgical Technology Laboratories, Inc.	1998-11-20	29
K983756	SURGIFORM ANATOMICAL MALAR	Surgical Technology Laboratories, Inc.	1998-11-20	29
K964443	SURGIFORM ANATOMICAL MALAR	Surgical Technology Laboratories, Inc.	1996-12-20	44
K840835	STRAITH DRAIN INSERTER	Surgical Technology Laboratories, Inc.	1984-04-23	59
K831078	STRAITH ORAL AIRWAY	Surgical Technology Laboratories, Inc.	1983-06-24	81
K801072	STRAITH NASAL SPLINT	Surgical Technology Laboratories, Inc.	1980-06-17	42
K801074	STRAITH NASAL IMPLANT	Surgical Technology Laboratories, Inc.	1980-06-17	42
K801075	STRAITH CHISEL FORCEPS	Surgical Technology Laboratories, Inc.	1980-05-20	14
K801073	STRAITH CHIN IMPLANTS	Surgical Technology Laboratories, Inc.	1980-05-20	14

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