Atlas FDA

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

Thermo Fisher Scientific — Predicate Candidate Screening

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

91 daysmedian FDA review time
257 days90th percentile
64clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2025-09-25860
K250575The Sensititre 18 - 24 hour MIC or Breakpoint SusceptibilityThermo Fisher Scientific2025-09-051910
K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2025-08-28620
K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2025-06-30910
K242843The Sensititre 20-24 hour Haemophilus influenzae/StreptococcThermo Fisher Scientific2025-06-202730
K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2025-05-222600
K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2025-04-152230
K243738The Sensititre YeastOne Susceptibility System with MicafungiThermo Fisher Scientific2025-02-27850
K243201The Sensititre 20-24 hour Haemophilus influenzae/StreptococcThermo Fisher Scientific2025-02-101320
K242905The Sensititre 20-24 hour Haemophilus influenzae/StreptococcThermo Fisher Scientific2025-02-101390
K243169The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2024-12-19800
K242653The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2024-12-05920
K242657The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2024-11-26830
K242021The Sensititre 20 - 24 hour Haemophilus influenzae/StreptocoThermo Fisher Scientific2024-10-09900
K241967The Sensititre 20 - 24 hour Haemophilus influenzae/StreptocoThermo Fisher Scientific2024-10-01900
K240445The Sensititre 20 - 24 hour Haemophilus influenzae/StreptocoThermo Fisher Scientific2024-05-16910
K232310Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pThermo Fisher Scientific2023-10-31900
K231433The Sensititre YeastOne Susceptibility System with RezafungiThermo Fisher Scientific2023-08-311060
K231988Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pThermo Fisher Scientific2023-08-30560
K231994Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2023-08-25510
K230935Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pThermo Fisher Scientific2023-06-30880
K223844Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pThermo Fisher Scientific2023-03-21890
K221198Sensititre YeastOne Susceptibility System with Fluconazole iThermo Fisher Scientific2023-03-103180
K221899The Sensititre YeastOne Susceptibility System with CaspofungThermo Fisher Scientific2023-01-202040
K203741Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2021-12-203630
K211539Sensititre YeastOne Susceptibility System with Voriconazole Thermo Fisher Scientific2021-12-152110
K202612Sensititre 20-24 hour Haemophilus influenzae /Streptococcus Thermo Fisher Scientific2021-07-233170
K193538Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2020-03-12830
K193024Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pThermo Fisher Scientific2020-01-08700
K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific2019-11-061111
K191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific2019-11-061120
K192729Sensititre 18-24 Hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2019-11-06400
K192250Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2019-10-16580
K183324Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pThermo Fisher Scientific2019-02-15770
K183033Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2019-01-04640
K182797Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2018-11-30600
K181946Sensititre 18-24 hour MIC Breakpoint Susceptibility System wThermo Fisher Scientific2018-08-08190
K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2017-12-01600
K172454Sensititre 18-24 hour MIC or Breakpoint Susceptibility SysteThermo Fisher Scientific2017-10-13600
K172274The Sensititre 20-24 hour Haemophilus influenzae/StreptococcThermo Fisher Scientific2017-08-30330
K171870The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2017-08-01400
K152774The Sensititre 18-24 hour MIC or Breakpoint Susceptibility SThermo Fisher Scientific2015-12-21870
K150556Sensititre 18-24 hours MIC or BP Susceptibility System with Thermo Fisher Scientific2015-08-281770
K150236Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility SysThermo Fisher Scientific2015-07-271750
K143288Sensititre Susceptibility platesThermo Fisher Scientific2015-04-011350
K143526The Sensititre HP MIC Susceptibility plate with Oritavancin Thermo Fisher Scientific2015-03-05830
K142338Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002Thermo Fisher Scientific2015-03-021930
K143381Sensititre Susceptibility PlatesThermo Fisher Scientific2015-02-19860
K142151SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESThermo Fisher Scientific2014-12-231390
K141651SENSITITRE SUSCEPTIBILITY PLATESThermo Fisher Scientific2014-10-211230

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