Oem Medical Div.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oem Medical Div.” (first 1977, latest 1993), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
Review panels
Most recent Oem Medical Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | GCX | 1993-08-05 | 329 |
| K925893 | OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT | CAI | 1993-03-12 | 115 |
| K922748 | GUEDEL AIRWAY | CAE | 1992-07-10 | 32 |
| K811855 | SKIN SCRUB KITS | KDD | 1981-07-31 | 30 |
| K761297 | MOUTHPIECE SEAL | BYP | 1977-01-03 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Oem Medical Div..
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 Oem Medical Div.?
FDA lists 5 510(k) clearances under the applicant name “Oem Medical Div.” (first 1977, latest 1993), across 5 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 Oem Medical Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oem Medical Div. is 32 days.
Which FDA product codes appear under Oem Medical Div.?
The most frequent FDA product codes under this applicant name are BYP (Mouthpiece, Breathing, 1); CAE (Airway, Oropharyngeal, Anesthesiology, 1); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1).
Next steps
- See all 5 Oem Medical Div. clearances with predicates and recalls
- Run predicate analysis for product code BYP, Oem Medical Div.'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.