Ziehm International, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Ziehm International, Inc.” (first 1982, latest 2001), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LDF | Electrode, Pacemaker, Temporary | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- General Hospital (8)
- Cardiovascular (5)
- Radiology (3)
Most recent Ziehm International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011292 | ZIEHM VISION | OWB | 2001-06-20 | 51 |
| K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR | FMI | 1991-02-14 | 13 |
| K902196 | MODIFIED STICK-GARD SAFETY NEEDLE | FPA | 1990-06-26 | 41 |
| K894021 | MOBILE X-RAY UNIT | IZL | 1989-09-01 | 87 |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | FRN | 1989-08-28 | 83 |
| K890620 | STICK-GARD SAFETY NEEDLE | FMI | 1989-02-28 | 21 |
| K882133 | MAMMO M | IZH | 1988-09-19 | 122 |
| K843311 | IV ADMIN. SET FOR MVP 1 INFUSION PUMP | FRN | 1985-03-13 | 202 |
| K842263 | MTP E.V. INFUSION PUMP | FRN | 1984-07-25 | 48 |
| K831407 | CARDIAC OUTPUT COMPUTER | DXG | 1983-10-14 | 165 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ziehm International, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ziehm International, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ziehm Imaging GmbH (25 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ziehm International, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Ziehm International, Inc.” (first 1982, latest 2001), across 10 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 Ziehm International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ziehm International, Inc. is 62 days.
Which FDA product codes appear under Ziehm International, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); FMI (Needle, Hypodermic, Single Lumen, 2); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 16 Ziehm International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Ziehm International, 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.