Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
BXP · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
211 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K936141 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-03-31 | 94 | 0 |
| K920360 | TIMOX OXYGEN TIMER | Medical Fittings, Inc. | 1992-08-03 | 189 | 0 |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Kells Medical, Inc. | 1984-03-07 | 211 | 0 |
| K800087 | ULTRASONIC FLOWMETER | The Perkin-Elmer Corp. | 1980-03-19 | 65 | 0 |
| K781039 | OXY-ON DIGITAL OXYGEN TIMER | Chambers & Sadler Mfg. | 1978-08-31 | 73 | 0 |
| K770424 | OXYGEN TWMER, MODEL SST | Timeter Instrument Corp. | 1977-03-16 | 9 | 0 |
| K761260 | ARIZONA OXYGEN TIMER DEVICE | The John Bunn Co. | 1976-12-16 | 8 | 0 |
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