Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

FCT · Predicate Candidate Screening

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

88 daysmedian FDA review time
182 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960767LIGHT COMMANDERScieran Technologies, Inc.1996-08-261820
K924198MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.1992-11-23950
K883480MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USESite Microsurgical Systems, Inc.1988-08-2480
K802769FIBER OPTIC HEADLIGHT #60-0765Aspen Laboratories, Inc.1980-12-11380
K802770FIBER OPTIC HEADLIGHT #60-0766766Aspen Laboratories, Inc.1980-12-11380
K780433FIBER OPTIC ADJUSTABLE HEADLIGHTCameron-Miller, Inc.1978-06-13880

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