Atlas FDA

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

FSQ · Predicate Candidate Screening

7 FDA 510(k) clearances under this product code; the 50 most recent screened below.

87 daysmedian FDA review time
236 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932139LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFTAaron Medical Industries1993-07-30870
K930686MIDMARK SURGICAL LIGHTING SYSTEMSMidmark Corp.1993-07-301700
K922409ALM ILLUMINATOR SERIES LIGHT SYSTEMAlm Surgical Equipment, Inc.1993-01-122360
K921848BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHTAlm Surgical Equipment, Inc.1992-10-011670
K803067SURG-FLEX 10 LIGHTMedical Products Development, Inc.1981-02-26840
K810019SURG-FLEX 15 SURGICAL LIGHTMedical Products Development, Inc.1981-01-23180
K810018SURG-FLEX 5 SURGICAL LIGHTMedical Products Development, Inc.1981-01-23180

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