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

Stephen Chakoff, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time
485 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940316HYSTERSCOPEStephen Chakoff, Inc.1995-11-166610
K940317SINUSCOPEStephen Chakoff, Inc.1995-05-244850
K950753CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIStephen Chakoff, Inc.1995-05-15870
K951082CHAKOFF ENDOSCOPY, RIGID ENDOSCOPEStephen Chakoff, Inc.1995-03-22130
K950748CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)Stephen Chakoff, Inc.1995-03-06170
K950744CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)Stephen Chakoff, Inc.1995-03-06170
K950746CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)Stephen Chakoff, Inc.1995-03-06170
K950745CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)Stephen Chakoff, Inc.1995-03-06170
K950747CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)Stephen Chakoff, Inc.1995-03-06170
K945421CHAKOFF ENDOSCOPYStephen Chakoff, Inc.1994-12-23490
K945420CHAKOFF ENDOSCOPYStephen Chakoff, Inc.1994-12-08340
K932632CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATIONStephen Chakoff, Inc.1994-06-213850
K932627CHAKOFF ENDOSCOPYStephen Chakoff, Inc.1994-02-042480
K932631XENON LIGHT SOURCE ILLUMINATORStephen Chakoff, Inc.1993-11-161680
K932629FIBER OPTIC LIGHT CABLEStephen Chakoff, Inc.1993-11-161680
K932628ENDOSCOPIC VIDEO CAMERAStephen Chakoff, Inc.1993-10-151360

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