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

Octostop, Inc. — Predicate Candidate Screening

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

168 daysmedian FDA review time
434 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972766PIVOTING COMPENSATING FILTERS FOR THE HEADOctostop, Inc.1997-08-14210
K963941THE PHARAOH COMPENSATING FILTEROctostop, Inc.1996-11-27570
K953246OCTOROLLOctostop, Inc.1995-09-29800
K952871RIDGES PLUSOctostop, Inc.1995-07-20510
K942916OCTOPAQUE UNIVERSALOctostop, Inc.1994-09-08790
K940306OCTOSTOP COMPENSATING FILTERSOctostop, Inc.1994-09-062370
K935444OCTOSTOP(R) CHAIR (NEW MODELOctostop, Inc.1994-09-022940
K930124VARIANT OF OCTOSTOP AND OCTOPAQUEOctostop, Inc.1994-02-093930
K930357ACCESSORY TO UNIVERSAL OCTOPAQUEOctostop, Inc.1993-07-131680
K926069WRIST TRACTIONOctostop, Inc.1993-01-21510
K913711GENTLE SLOPEOctostop, Inc.1992-10-144340
K913659LITTLE PRISMOctostop, Inc.1992-10-144340
K910757THE BULLIONOctostop, Inc.1991-09-162520

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