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

Liofilchem s.r.l. · Predicate Candidate Screening

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

62 daysmedian FDA review time

99 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K260696	MTS Gepotidacin 0.016-256 µg/mL	Liofilchem s.r.l.	2026-04-17	45
K252114	MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL	Liofilchem s.r.l.	2025-10-02	87
K251580	MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)	Liofilchem s.r.l.	2025-08-20	89
K243202	MTS Ceftobiprole 0.002-32 µg/mL	Liofilchem s.r.l.	2025-01-30	121
K230479	ComASP Cefiderocol 0.008-128	Liofilchem s.r.l.	2023-05-18	85
K211672	MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL	Liofilchem s.r.l.	2021-10-20	141
K200180	MTS Omadacycline 0.002 - 32 ug/mL	Liofilchem s.r.l.	2020-03-20	56
K192345	MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL	Liofilchem s.r.l.	2019-10-31	63
K191908	MTS Imipenem 0.016-256 µg/mL	Liofilchem s.r.l.	2019-09-04	50
K191809	MTS Imipenem-relebactam 0.002/4-32/4 µg/mL	Liofilchem s.r.l.	2019-08-23	49
K190914	MTS Doxycycline 0.016 - 256 µg/mL	Liofilchem s.r.l.	2019-05-29	51
K190252	MTS Gentamicin 0.016 - 256 µg/mL	Liofilchem s.r.l.	2019-03-22	43
K183527	MTS Ciprofloxacin 0.002 - 32 µg/mL	Liofilchem s.r.l.	2019-03-19	90
K183140	MTS Tetracycline 0.016 - 256 ug/mL	Liofilchem s.r.l.	2019-01-11	59
K183115	MTS Levofloxacin 0.002 - 32 µg/mL	Liofilchem s.r.l.	2018-12-20	41
K182922	MTS Omadacycline 0.002-32 µg/mL	Liofilchem s.r.l.	2018-12-14	56
K182557	MTS Eravacycline 0.002 - 32 µg/mL	Liofilchem s.r.l.	2018-11-02	46
K181889	MTS Penicillin 0.002- 32 µg/mL	Liofilchem s.r.l.	2018-09-13	62
K181708	MTS Plazomicin 0.016-256 µg/mL	Liofilchem s.r.l.	2018-07-31	33
K180886	Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/	Liofilchem s.r.l.	2018-05-18	44
K180339	Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg	Liofilchem s.r.l.	2018-04-04	56
K180330	Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL	Liofilchem s.r.l.	2018-03-15	37
K173817	Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016	Liofilchem s.r.l.	2018-02-28	75
K173307	Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016	Liofilchem s.r.l.	2017-12-19	62
K172542	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.	Liofilchem s.r.l.	2017-10-23	61
K172109	Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg	Liofilchem s.r.l.	2017-09-27	76
K171906	Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/	Liofilchem s.r.l.	2017-08-01	36
K170772	Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/	Liofilchem s.r.l.	2017-06-07	85
K170892	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL	Liofilchem s.r.l.	2017-05-25	59
K163517	Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/	Liofilchem s.r.l.	2017-03-14	89
K163298	Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg	Liofilchem s.r.l.	2017-02-22	92
K162854	Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml	Liofilchem s.r.l.	2016-12-19	68
K161175	Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.01	Liofilchem s.r.l.	2016-07-12	77
K153569	Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 u	Liofilchem s.r.l.	2016-06-22	190
K153687	Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL	Liofilchem s.r.l.	2016-03-31	99

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