New Dimensions IN Medicine, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “New Dimensions IN Medicine, Inc.” (first 1977, latest 1992), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| EHE | Dispenser, Mercury And/Or Alloy | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
| JOS | Electrode, Electrosurgical | 1 | 1 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 1 | 1 |
Review panels
- Neurology (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Dental (1)
Most recent New Dimensions IN Medicine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | NAE | 1992-04-21 | 67 |
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | GXY | 1983-07-19 | 14 |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | FLS | 1982-10-06 | 83 |
| K780631 | NDM INFANT ECG PACKPAD | GYB | 1978-05-03 | 16 |
| K780405 | INFANT ELECTROSURGICAL GROUNDING PAD | JOS | 1978-04-05 | 23 |
| K771749 | AMALGAM DISPENSER | EHE | 1977-09-28 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named New Dimensions IN Medicine, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under New Dimensions IN Medicine, Inc.?
FDA lists 6 510(k) clearances under the applicant name “New Dimensions IN Medicine, Inc.” (first 1977, latest 1992), 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 New Dimensions IN Medicine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Dimensions IN Medicine, Inc. is 20 days.
Which FDA product codes appear under New Dimensions IN Medicine, Inc.?
The most frequent FDA product codes under this applicant name are EHE (Dispenser, Mercury And/Or Alloy, 1); FLS (Monitor, Apnea, Facility Use, 1); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 6 New Dimensions IN Medicine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EHE, New Dimensions IN Medicine, 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, 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.