Life Technologies Corporation: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Life Technologies Corporation” (first 1995, latest 2025), plus 2 PMA and 1 De Novo decisions, across 8 product codes in 6 review panels. Median 510(k) review time under this name: 128 days. Since 2017 the median was 232 days, against 180 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 202 |
| 2013 | 1 | 77 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 142 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 309 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 264 |
| 2025 | 1 | 201 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Life Technologies Corporation took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 4 | 3 |
| MFD | Cannula, Intrauterine Insemination | 2 | 2 |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 2 | 0 |
| OOI | Real Time Nucleic Acid Amplification System | 1 | 1 |
| PCA | Dna Genetic Analyzer | 1 | 1 |
| PFF | High Throughput Dna Sequence Analyzer | 1 | 1 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 1 | 1 |
Review panels
- Gastroenterology and Urology (4)
- Clinical Chemistry (2)
- Microbiology (2)
- Obstetrics and Gynecology (2)
- Pathology (2)
- Clinical Toxicology (1)
Most recent Life Technologies Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | QOF | 2025-01-08 | 201 |
| K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | QQX | 2024-07-10 | 264 |
| K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | PCA | 2020-02-21 | 309 |
| K170299 | Ion PGM Dx System | PFF | 2017-06-22 | 142 |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | OOI | 2013-03-08 | 77 |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | NDS | 2012-06-21 | 202 |
| K103302 | STEMPRO MSC SFM | NDS | 2011-02-18 | 101 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | NDS | 2010-05-20 | 77 |
| K953719 | HUMAN TUBAL FLUID | MFD | 1995-11-06 | 89 |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | MFD | 1995-08-11 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240040 | PMA | Oncomine Dx Express Test | 2025-07-02 |
| P160045 | PMA | Oncomine Dx Target Test | 2017-06-22 |
| DEN000008 | De Novo | Media, Culture, Ex Vivo, Tissue And Cell | 2001-02-16 |
Recalls
24 product recalls in 11 recall events; 1 initiated in the last five years. Most recent: 2024-02-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Life Spine, Inc. (123 510(k)s)
- Life Design Systems, Inc. (29 510(k)s)
- Life Science Instrumentation, Inc. (20 510(k)s)
- Life Support Products, Inc. (20 510(k)s)
- Life Shield Healthcare Products, Inc. (17 510(k)s)
- Life Sciences Manufacturing, Inc. (12 510(k)s)
- Life Products, Inc. (10 510(k)s)
- Life Corp. (5 510(k)s)
- Life Sensing Instrument Company, Inc. (5 510(k)s)
- Life Enhancement Technologies, LLC (3 510(k)s)
- Life Global Group, LLC (3 510(k)s)
- Life Medical Sciences, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life Technologies Corporation?
FDA lists 10 510(k) clearances under the applicant name “Life Technologies Corporation” (first 1995, latest 2025), plus 2 PMA and 1 De Novo decisions, across 8 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Life Technologies Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life Technologies Corporation is 128 days. Since 2017: 232 days, versus 180 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Life Technologies Corporation?
The most frequent FDA product codes under this applicant name are NDS (Media, Culture, Ex Vivo, Tissue And Cell, 4); MFD (Cannula, Intrauterine Insemination, 2); PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 2).
Next steps
- See all 10 Life Technologies Corporation clearances with predicates and recalls
- Run predicate analysis for product code NDS, Life Technologies Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.