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

JWY — Predicate Candidate Screening

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

69 daysmedian FDA review time

175 days90th percentile

441clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260447	ETEST Gepotidacin (GEP) (0.016-256 µg/mL)	bioMérieux SA	2026-04-21	69	0
K260696	MTS Gepotidacin 0.016-256 µg/mL	Liofilchem s.r.l.	2026-04-17	45	0
K252114	MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL	Liofilchem s.r.l.	2025-10-02	87	0
K252062	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2025-09-25	86	0
K250575	The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility	Thermo Fisher Scientific	2025-09-05	191	0
K252014	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2025-08-28	62	0
K251580	MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)	Liofilchem s.r.l.	2025-08-20	89	0
K250990	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2025-06-30	91	0
K242843	The Sensititre 20-24 hour Haemophilus influenzae/Streptococc	Thermo Fisher Scientific	2025-06-20	273	0
K250856	ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)	Biomérieux	2025-06-12	83	0
K242659	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2025-05-22	260	0
K250274	ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/	Biomerieux S.A.	2025-04-30	90	0
K242658	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2025-04-15	223	0
K243201	The Sensititre 20-24 hour Haemophilus influenzae/Streptococc	Thermo Fisher Scientific	2025-02-10	132	0
K242905	The Sensititre 20-24 hour Haemophilus influenzae/Streptococc	Thermo Fisher Scientific	2025-02-10	139	0
K243202	MTS Ceftobiprole 0.002-32 µg/mL	Liofilchem s.r.l.	2025-01-30	121	0
K243169	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2024-12-19	80	0
K242653	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2024-12-05	92	0
K242657	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility S	Thermo Fisher Scientific	2024-11-26	83	0
K242021	The Sensititre 20 - 24 hour Haemophilus influenzae/Streptoco	Thermo Fisher Scientific	2024-10-09	90	0
K241967	The Sensititre 20 - 24 hour Haemophilus influenzae/Streptoco	Thermo Fisher Scientific	2024-10-01	90	0
K240445	The Sensititre 20 - 24 hour Haemophilus influenzae/Streptoco	Thermo Fisher Scientific	2024-05-16	91	0
K232310	Sensititre 20-24 hour Haemophilus influenzaelStreptococcus p	Thermo Fisher Scientific	2023-10-31	90	0
K232395	ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETE	Biomérieux	2023-10-05	57	0
K231988	Sensititre 20-24-hour Haemophilus influenzae/Streptococcus p	Thermo Fisher Scientific	2023-08-30	56	0
K231994	Sensititre 18-24 hour MIC or Breakpoint Susceptibility Syste	Thermo Fisher Scientific	2023-08-25	51	0
K230935	Sensititre 20-24 hour Haemophilus influenzae/Streptococcus p	Thermo Fisher Scientific	2023-06-30	88	0
K230479	ComASP Cefiderocol 0.008-128	Liofilchem s.r.l.	2023-05-18	85	0
K223844	Sensititre 20-24-hour Haemophilus influenzae/Streptococcus p	Thermo Fisher Scientific	2023-03-21	89	0
K203741	Sensititre 18-24 hour MIC or Breakpoint Susceptibility Syste	Thermo Fisher Scientific	2021-12-20	363	0
K210757	ETEST Fosfomycin (FO) (0.032-512 µg/mL)	Biomerieux S.A.	2021-11-12	242	0
K211672	MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL	Liofilchem s.r.l.	2021-10-20	141	0
K202612	Sensititre 20-24 hour Haemophilus influenzae /Streptococcus	Thermo Fisher Scientific	2021-07-23	317	0
K202423	MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16	Beckman Coulter, Inc.	2021-05-18	266	0
K200512	ETEST Plazomicin (PLZ) (0.016-256 µg/mL)	Biomérieux SA	2020-05-07	66	0
K200308	MTS Lefamulin 0.016- 256 µg/mL	Liofilchem S. R. 1.	2020-04-06	60	0
K200180	MTS Omadacycline 0.002 - 32 ug/mL	Liofilchem s.r.l.	2020-03-20	56	0
K193538	Sensititre 18-24 hour MIC or Breakpoint Susceptibility Syste	Thermo Fisher Scientific	2020-03-12	83	0
K193024	Sensititre 20-24 hour Haemophilus influenzae/Streptococcus p	Thermo Fisher Scientific	2020-01-08	70	0
K192738	ETEST Delafloxacin (DFX) (0.002-32 µg/mL)	Biomerieux S.A.	2019-11-26	60	0
K192355	MicroScan Dried Gram Negative MIC/Combo Panels with Meropene	Beckman Coulter, Inc.	2019-11-14	77	0
K192729	Sensititre 18-24 Hour MIC or Breakpoint Susceptibility Syste	Thermo Fisher Scientific	2019-11-06	40	0
K192345	MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL	Liofilchem s.r.l.	2019-10-31	63	0
K192250	Sensititre 18-24 hour MIC or Breakpoint Susceptibility Syste	Thermo Fisher Scientific	2019-10-16	58	0
K192050	ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)	Biomerieux S.A.	2019-09-27	58	1
K191908	MTS Imipenem 0.016-256 µg/mL	Liofilchem s.r.l.	2019-09-04	50	0
K191809	MTS Imipenem-relebactam 0.002/4-32/4 µg/mL	Liofilchem s.r.l.	2019-08-23	49	0
K191953	ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)	Biomerieux S.A.	2019-08-22	31	1
K190914	MTS Doxycycline 0.016 - 256 µg/mL	Liofilchem s.r.l.	2019-05-29	51	0
K190154	ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)	Biomerieux S.A.	2019-05-01	91	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