Inter-Med, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under 2 spellings of the applicant name “Inter-Med, Inc.” (first 1984, latest 2026), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 166 days, against 152 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.
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 | 1 | 181 |
| 2022 | 1 | 152 |
| 2023 | 0 | — |
| 2024 | 2 | 102 |
| 2025 | 1 | 229 |
| 2026 | 1 | 197 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inter-Med, Inc. took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | 3 | 3 |
| FAD | Stent, Ureteral | 2 | 2 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 1 | 1 |
Review panels
Most recent Inter-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253337 | REGEN Bioactive Cement | EMA | 2026-04-15 | 197 |
| K241489 | ReminGel | LBH | 2025-01-08 | 229 |
| K241457 | Vista BC Putty | KIF | 2024-08-28 | 97 |
| K241354 | Sealer Solvent | KJJ | 2024-08-27 | 106 |
| K221811 | Vista BC Sealer | KIF | 2022-11-21 | 152 |
| K211721 | PS System | NYL | 2021-12-02 | 181 |
| K112250 | CHX=CHX PLUS | KJJ | 2011-10-28 | 85 |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | KJJ | 2009-04-03 | 219 |
| K871291 | AM CATH ESWL STENT | FAD | 1987-04-30 | 30 |
| K864669 | AM CATH ESWL STENT | FAD | 1987-01-05 | 34 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Inter-Med, Inc..
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:
- Inter-Med, Inc. (8)
- Inter-Med Corp. (4)
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.
- Inter-Med/Vista Dental Products (6 510(k)s)
- Inter Med Industries, Inc. (3 510(k)s)
- Inter Medical Medizintechnik GmbH (3 510(k)s)
- Inter Science Institute (3 510(k)s)
- Inter Continental Health Care (2 510(k)s)
- Inter-Asia Co., Inc. (1 510(k)s)
- Inter-Continental Industries Sdn Bhd (1 510(k)s)
- Inter-Med / Vista Dental (1 510(k)s)
- Inter-Os Technologies (1 510(k)s)
- Inter-Os Technologies, LLC (1 510(k)s)
- Inter-Pal GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inter-Med, Inc.?
FDA lists 12 510(k) clearances under 2 spellings of the applicant name “Inter-Med, Inc.” (first 1984, latest 2026), across 8 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 Inter-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inter-Med, Inc. is 126 days. Since 2017: 166 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inter-Med, Inc.?
The most frequent FDA product codes under this applicant name are KJJ (Cleanser, Root Canal, 3); FAD (Stent, Ureteral, 2); KIF (Resin, Root Canal Filling, 2).
Next steps
- See all 12 Inter-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KJJ, Inter-Med, Inc.'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.