Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ziehm International, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
165 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011292 | ZIEHM VISION | Ziehm International, Inc. | 2001-06-20 | 51 | 0 |
| K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR | Ziehm International, Inc. | 1991-02-14 | 13 | 0 |
| K902196 | MODIFIED STICK-GARD SAFETY NEEDLE | Ziehm International, Inc. | 1990-06-26 | 41 | 0 |
| K894021 | MOBILE X-RAY UNIT | Ziehm International, Inc. | 1989-09-01 | 87 | 0 |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | Ziehm International, Inc. | 1989-08-28 | 83 | 0 |
| K890620 | STICK-GARD SAFETY NEEDLE | Ziehm International, Inc. | 1989-02-28 | 21 | 0 |
| K882133 | MAMMO M | Ziehm International, Inc. | 1988-09-19 | 122 | 0 |
| K843311 | IV ADMIN. SET FOR MVP 1 INFUSION PUMP | Ziehm International, Inc. | 1985-03-13 | 202 | 0 |
| K842263 | MTP E.V. INFUSION PUMP | Ziehm International, Inc. | 1984-07-25 | 48 | 0 |
| K831407 | CARDIAC OUTPUT COMPUTER | Ziehm International, Inc. | 1983-10-14 | 165 | 0 |
| K830453 | IV ADMINISTRATION SETS - MVP INFUSION | Ziehm International, Inc. | 1983-04-30 | 74 | 0 |
| K830454 | IMS MINIATURE VOLUMETRIC INFUSION PUMP | Ziehm International, Inc. | 1983-03-31 | 44 | 0 |
| K822003 | BALLOON TEMP. PACING CATHETER | Ziehm International, Inc. | 1982-10-15 | 99 | 0 |
| K822002 | BIPOLAR TEMP. PACING CATHETER W/STYLETET | Ziehm International, Inc. | 1982-10-15 | 99 | 0 |
| K822034 | BALLOON WEDGE PRESSURE CATHETER | Ziehm International, Inc. | 1982-08-24 | 43 | 0 |
| K822033 | BERMAN ANGIOGRAPHIC BALLOON CATHETER | Ziehm International, Inc. | 1982-08-24 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda