Jobst Institute, Inc.: FDA clearances and approvals
Jobst Institute, Inc. has 15 FDA 510(k) clearances (first 1988, latest 1995), across 7 product codes in 3 review panels. Median 510(k) review time: 86 days.
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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 6 | 6 |
| JOW | Sleeve, Limb, Compressible | 4 | 4 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| LHX | Trousers, Anti-Shock | 1 | 1 |
| MCY | Wound Dressing Kit | 1 | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
Review panels
Most recent Jobst Institute, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955138 | ANTI-EM/GP STOCKINGS | DWL | 1995-12-13 | 30 |
| K953763 | GLADIATOR ANTISHOCK PANTS | LHX | 1995-11-28 | 109 |
| K925583 | JOBSKIN CONTINUING CARE | MDA | 1994-04-04 | 515 |
| K925154 | JOBST-CUSTOM | DWL | 1994-04-04 | 538 |
| K934639 | JOBST ATHROMBIC PUMP - SYSTEM 2500 | JOW | 1994-02-09 | 133 |
| K922681 | CUTINOVA FOAM | KMF | 1992-08-31 | 88 |
| K921562 | JOBST EXTREMITY PUMP SYSTEM 7500 | JOW | 1992-06-22 | 82 |
| K920444 | ULTIMATE | DWL | 1992-04-20 | 77 |
| K912232 | ULCERCARE | MCY | 1991-08-14 | 86 |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | KCZ | 1991-03-29 | 8 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jobst Institute, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jobst Institute, Inc. have?
Jobst Institute, Inc. has 15 FDA 510(k) clearances (first 1988, latest 1995), across 7 product codes in 3 review panels.
How long does FDA take to clear Jobst Institute, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jobst Institute, Inc.'s cleared 510(k)s is 86 days.
What devices does Jobst Institute, Inc. make?
Its most frequent FDA product codes are DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), 6); JOW (Sleeve, Limb, Compressible, 4); KCZ (Prosthesis, Breast, External, Used With Adhesive, 1).
Has Jobst Institute, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jobst Institute, Inc. Related entities may recall under other names.
Next steps
- See all 15 Jobst Institute, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWL, Jobst Institute, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.