Kretztechnik AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kretztechnik AG” (first 1990, latest 1993), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 190 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (6)
Most recent Kretztechnik AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925354 | COMBISON(R) 311 | IYO | 1993-07-08 | 259 |
| K904070 | COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A | IYO | 1992-10-09 | 766 |
| K910966 | SECTOR TRANSDUCER MODEL NO. AWP3.5/A | ITX | 1992-04-17 | 408 |
| K904665 | MODEL IW17.5A INTRA OPERATIVE TRANSDUCER | ITX | 1991-01-11 | 88 |
| K901725 | ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A | ITX | 1990-08-15 | 121 |
| K901655 | 1 TRANSDUCER FOR COMBISON 310A | ITX | 1990-07-20 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Kretztechnik AG.
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 Kretztechnik AG?
FDA lists 6 510(k) clearances under the applicant name “Kretztechnik AG” (first 1990, latest 1993), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kretztechnik AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kretztechnik AG is 190 days.
Which FDA product codes appear under Kretztechnik AG?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 6 Kretztechnik AG clearances with predicates and recalls
- Run predicate analysis for product code ITX, Kretztechnik AG'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.