Remel Co.: FDA filings under this applicant name
FDA lists 154 510(k) clearances under 2 spellings of the applicant name “Remel Co.” (first 1979, latest 2017), across 42 product codes in 4 review panels. Median 510(k) review time under this name: 54 days. 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 | 0 | — |
| 2013 | 1 | 23 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 223 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Remel Co. took a median 223 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 49 | 49 |
| JTN | Susceptibility Test Discs, Antimicrobial | 14 | 14 |
| JTS | Stains, Microbiologic | 12 | 12 |
| JSJ | Culture Media, Selective And Non-Differential | 11 | 11 |
| JSI | Culture Media, Selective And Differential | 9 | 9 |
| JSM | Culture Media, Non-Propagating Transport | 5 | 5 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 5 | 5 |
| LIO | Device, Specimen Collection | 5 | 5 |
| JSF | Culture Media, Single Biochemical Test | 4 | 4 |
| JSN | Culture Media, Propagating Transport | 2 | 2 |
Plus 32 more product codes.
Review panels
- Microbiology (148)
- Pathology (4)
- Clinical Chemistry (1)
- Hematology (1)
Most recent Remel Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162620 | Remel Spectra ESBL | JSO | 2017-05-01 | 223 |
| K131804 | REMEL XPECT FLU A&B | GNX | 2013-07-12 | 23 |
| K092407 | REMEL SPECTRA MRSA | JSO | 2010-10-08 | 428 |
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | MJE | 2007-11-26 | 54 |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | LLH | 2004-11-15 | 118 |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | LLH | 2004-02-26 | 115 |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | MHI | 2003-11-18 | 147 |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | MHJ | 2003-11-14 | 141 |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | MHI | 2003-11-10 | 150 |
| K031565 | XPECT INFLUENZA A/B | PSZ | 2003-07-17 | 59 |
144 earlier clearances. See the full list in Caduvo.
Recalls
113 product recalls in 74 recall events; 25 initiated in the last five years. Most recent: 2026-06-03.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Remel Co. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via PSZ)
- J0702 — Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg (via IGB)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Remel Co. (137)
- Remel, Inc. (17)
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.
- Remel, L.P. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Remel Co.?
FDA lists 154 510(k) clearances under 2 spellings of the applicant name “Remel Co.” (first 1979, latest 2017), across 42 product codes in 4 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 Remel Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remel Co. is 54 days.
Which FDA product codes appear under Remel Co.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 49); JTN (Susceptibility Test Discs, Antimicrobial, 14); JTS (Stains, Microbiologic, 12).
Next steps
- See all 154 Remel Co. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Remel Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.