Thermo Fisher Scientific: FDA clearances and approvals
Thermo Fisher Scientific has 65 FDA 510(k) clearances (first 2007, latest 2025), across 13 product codes in 4 review panels. Median 510(k) review time: 91 days. Since 2017 its median was 89 days, against 86 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named Thermo Fisher Scientific. It files with the SEC as THERMO FISHER SCIENTIFIC INC. (TMO).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 257 |
| 2014 | 6 | 106 |
| 2015 | 7 | 135 |
| 2016 | 0 | — |
| 2017 | 4 | 50 |
| 2018 | 2 | 40 |
| 2019 | 6 | 70 |
| 2020 | 2 | 76 |
| 2021 | 3 | 317 |
| 2022 | 0 | — |
| 2023 | 8 | 90 |
| 2024 | 6 | 90 |
| 2025 | 10 | 136 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Thermo Fisher Scientific's cleared 510(k)s took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 47 | 47 |
| NGZ | Susceptibility Test Plate, Antifungal | 5 | 5 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 2 | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| DLJ | Calibrators, Drug Specific | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (57)
- Clinical Toxicology (5)
- Clinical Chemistry (2)
- Immunology (1)
Most recent Thermo Fisher Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | JWY | 2025-09-25 | 86 |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | JWY | 2025-09-05 | 191 |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | JWY | 2025-08-28 | 62 |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | JWY | 2025-06-30 | 91 |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | JWY | 2025-06-20 | 273 |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | JWY | 2025-05-22 | 260 |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | JWY | 2025-04-15 | 223 |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | NGZ | 2025-02-27 | 85 |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | JWY | 2025-02-10 | 132 |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | JWY | 2025-02-10 | 139 |
55 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2021-02-01.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
THERMO FISHER SCIENTIFIC INC. (TMO): EDGAR filings, CIK 97745. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Thermo Fisher Scientific's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Thermo Fisher Scientific have?
Thermo Fisher Scientific has 65 FDA 510(k) clearances (first 2007, latest 2025), across 13 product codes in 4 review panels.
How long does FDA take to clear Thermo Fisher Scientific's 510(k)s?
The median time from FDA receipt to decision across Thermo Fisher Scientific's cleared 510(k)s is 91 days. Since 2017: 89 days, versus 86 days for all cleared 510(k)s in the same product codes.
What devices does Thermo Fisher Scientific make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 47); NGZ (Susceptibility Test Plate, Antifungal, 5); JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, 2).
Has Thermo Fisher Scientific had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches Thermo Fisher Scientific; the most recent began 2021-02-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 65 Thermo Fisher Scientific clearances with predicates and recalls
- Run predicate analysis for product code JWY, Thermo Fisher Scientific's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.