Jerome Medical: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Jerome Medical” (first 1982, latest 2005), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | 3 | 3 |
| HAX | Tong, Skull For Traction | 2 | 2 |
| HXC | Wrench | 1 | 1 |
| ILZ | Accessories, Traction | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
Review panels
- Orthopedic (4)
- Neurology (2)
- Physical Medicine (2)
- General and Plastic Surgery (1)
Most recent Jerome Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051918 | RESOLVE OPEN BACK HALO RINGS | HAX | 2005-08-17 | 33 |
| K930021 | J TONGS | HAX | 1995-12-06 | 1065 |
| K930153 | SYSTEM III HALO RING | JEC | 1993-08-06 | 206 |
| K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE | JEC | 1988-09-30 | 81 |
| K870053 | TORQUEDRIVER WRENCH | HXC | 1987-03-11 | 63 |
| K864969 | JMS HALO APPLICATION TRAY | KDD | 1987-02-18 | 58 |
| K844490 | TRACTION ACCESSORIES | ILZ | 1985-02-21 | 93 |
| K822780 | CERVICAL BRACE | JEC | 1982-10-06 | 22 |
| K821582 | WARM'N FORM SPORTS SUPPORTS | IQI | 1982-06-10 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Jerome Medical.
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.
- Jerome Instrument Corp. (1 510(k)s)
- Jerome M. Simon (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jerome Medical?
FDA lists 9 510(k) clearances under the applicant name “Jerome Medical” (first 1982, latest 2005), across 6 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 Jerome Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jerome Medical is 63 days.
Which FDA product codes appear under Jerome Medical?
The most frequent FDA product codes under this applicant name are JEC (Component, Traction, Invasive, 3); HAX (Tong, Skull For Traction, 2); HXC (Wrench, 1).
Next steps
- See all 9 Jerome Medical clearances with predicates and recalls
- Run predicate analysis for product code JEC, Jerome Medical'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.