E.M. Adams: FDA filings under this applicant name
FDA lists 23 510(k) clearances under 2 spellings of the applicant name “E.M. Adams” (first 1978, latest 1997), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 3 | 3 |
| EAJ | Apron, Leaded | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| FMQ | Restraint, Protective | 2 | 2 |
| KDD | Kit, Surgical Instrument, Disposable | 2 | 2 |
| FPP | Stretcher, Hand-Carried | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FZI | Apparatus, Air Handling, Enclosure | 1 | 1 |
| FZT | Cutter, Surgical | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (12)
- General Hospital (6)
- Radiology (2)
Most recent E.M. Adams 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971948 | PATIENT RESTRAINT | FMQ | 1997-08-06 | 70 |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | FMQ | 1997-07-01 | 64 |
| K905173 | SPLASH GUARD | KYZ | 1991-04-25 | 160 |
| K910468 | STERILE DISPOSABLE DRAPE(S) | FZI | 1991-03-21 | 45 |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | GEN | 1987-11-23 | 54 |
| K850063 | INSTRUMENT POCKET | — | 1985-02-21 | 44 |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | KKX | 1985-01-10 | 108 |
| K843783 | WET PACK | EFQ | 1984-12-19 | 84 |
| K843782 | DRY TRAY | EFQ | 1984-12-13 | 78 |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | FSM | 1984-10-23 | 29 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named E.M. Adams.
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.
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:
- E.M. Adams (21)
- E.M. Adams Co., Inc. (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under E.M. Adams?
FDA lists 23 510(k) clearances under 2 spellings of the applicant name “E.M. Adams” (first 1978, latest 1997), across 16 product codes in 3 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 E.M. Adams?
The median time from FDA receipt to decision across 510(k)s cleared under the name E.M. Adams is 58 days.
Which FDA product codes appear under E.M. Adams?
The most frequent FDA product codes under this applicant name are FSM (Tray, Surgical, Instrument, 3); EAJ (Apron, Leaded, 2); EFQ (Gauze/Sponge, Internal, 2).
Next steps
- See all 23 E.M. Adams clearances with predicates and recalls
- Run predicate analysis for product code FSM, E.M. Adams'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.