Iob Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Iob Medical, Inc.” (first 2014, latest 2023), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 201 days. Since 2017 the median was 208 days, against 138 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 |
|---|---|---|
| 2014 | 1 | 143 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 214 |
| 2018 | 0 | — |
| 2019 | 1 | 262 |
| 2020 | 0 | — |
| 2021 | 1 | 265 |
| 2022 | 1 | 201 |
| 2023 | 2 | 42 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Iob Medical, Inc. took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 5 | 5 |
| FXX | Mask, Surgical | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
Review panels
Most recent Iob Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232638 | FilteredFlo Warming Blankets | DWJ | 2023-10-24 | 55 |
| K231596 | IOB Temperature Management System | DWJ | 2023-06-30 | 29 |
| K221669 | IOB Warming Blankets | DWJ | 2022-12-27 | 201 |
| K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | FXX | 2021-03-30 | 265 |
| K190221 | IOB Warming Blankets | DWJ | 2019-10-25 | 262 |
| K162679 | IOB Temperature Management System | DWJ | 2017-04-28 | 214 |
| K132668 | IOB DISPOSABLE SPECULUM | HIB | 2014-01-17 | 143 |
Recalls
openFDA lists no recalls under a recalling firm named Iob Medical, 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 Iob Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Iob Medical, Inc.” (first 2014, latest 2023), across 3 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 Iob Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iob Medical, Inc. is 201 days. Since 2017: 208 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Iob Medical, Inc.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 5); FXX (Mask, Surgical, 1); HIB (Speculum, Vaginal, Nonmetal, 1).
Next steps
- See all 7 Iob Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Iob Medical, 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.