Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

BXX — Predicate Candidate Screening

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

49 daysmedian FDA review time

134 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K923397	SINGLE DOSE GAS INJECTOR	Escalon Medical Trek	1992-09-14	66
K875075	RT-200 COMPUTER INTERFACE	Timeter Instrument Corp.	1988-04-21	134
K850029	UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL	Utah Medical Products, Inc.	1985-04-29	115
K822746	RT-200 CALIBRATION ANALYZER	Timeter Instrument Corp.	1982-10-13	33
K801256	NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY	Kleen Test Products	1980-06-04	7
K801257	NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.	Kleen Test Products	1980-06-04	7
K801258	NEEDLE COUNTER-SURE COUNT/10 COUNT	Kleen Test Products	1980-06-04	7
K791294	SPIROCAL	Equilibrated Bio Systems, Inc.	1979-08-16	37
K780981	PORTABLE PNEUMATIC CALIBRATOR 65-150	Pennwalt Corp.	1978-08-02	49
K780838	PERCI	Micro Tronics Corp.	1978-07-17	56

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