Pausch Corp.: FDA clearances and approvals
Pausch Corp. has 9 FDA 510(k) clearances (first 1979, latest 2008), across 7 product codes in 1 review panel. Median 510(k) review time: 27 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (9)
Most recent Pausch Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081073 | HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F | OWB | 2008-12-05 | 234 |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | IZF | 1998-06-17 | 251 |
| K973834 | CS2000 & CS2000 TOMO | IZF | 1998-04-30 | 204 |
| K903395 | UROMAT 2000 | IXR | 1990-08-30 | 34 |
| K870856 | COSMOS | IYB | 1987-03-30 | 27 |
| K790742 | KS-78 VERTICAL WALL CASSETTE HOLDER | IXY | 1979-04-26 | 10 |
| K790741 | COMPACT SYSTEM | KPR | 1979-04-26 | 10 |
| K790740 | BS 66, UNIVERSAL BUCKY STAND | KPR | 1979-04-26 | 10 |
| K790743 | COORDINATUS, HORIZONTAL RADIOGRAPHOC | KXJ | 1979-04-23 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Pausch Corp..
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 Pausch Corp. have?
Pausch Corp. has 9 FDA 510(k) clearances (first 1979, latest 2008), across 7 product codes in 1 review panel.
How long does FDA take to clear Pausch Corp.'s 510(k)s?
The median time from FDA receipt to decision across Pausch Corp.'s cleared 510(k)s is 27 days.
What devices does Pausch Corp. make?
Its most frequent FDA product codes are IZF (System, X-Ray, Tomographic, 2); KPR (System, X-Ray, Stationary, 2); IXR (Table, Radiographic, Tilting, 1).
Has Pausch Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pausch Corp. Related entities may recall under other names.
Next steps
- See all 9 Pausch Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZF, Pausch Corp.'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.