Zimmar Consulting , Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Zimmar Consulting , Ltd.” (first 1984, latest 1986), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 4 |
| FMF | Syringe, Piston | 3 | 3 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (8)
- Gastroenterology and Urology (5)
- Anesthesiology (2)
- Microbiology (1)
- General and Plastic Surgery (1)
Most recent Zimmar Consulting , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860322 | CLINISET INFUSION SET | FPA | 1986-04-07 | 68 |
| K843478 | PHARMA-PLAST URIDROP-URIDOME | KNX | 1984-12-05 | 90 |
| K843477 | PHARMA-PLAST RECTAL TIP | FCF | 1984-12-05 | 90 |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | GEA | 1984-11-23 | 78 |
| K843469 | PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- | JOL | 1984-11-19 | 74 |
| K843467 | PHARMA-PLAST NASAL OXYGEN CANNULA | CAT | 1984-11-19 | 74 |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | BZB | 1984-11-19 | 74 |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | BYY | 1984-11-16 | 71 |
| K843475 | PHARMA-PLAST SINGLE USE OVERSHOES | FXP | 1984-10-31 | 55 |
| K843473 | PHARMA-PLAST INSULIN SYRINGE | FMF | 1984-10-31 | 55 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zimmar Consulting , Ltd..
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 Zimmar Consulting , Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Zimmar Consulting , Ltd.” (first 1984, latest 1986), across 12 product codes in 5 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 Zimmar Consulting , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmar Consulting , Ltd. is 55 days.
Which FDA product codes appear under Zimmar Consulting , Ltd.?
The most frequent FDA product codes under this applicant name are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 4); FMF (Syringe, Piston, 3); BYY (Tube, Aspirating, Flexible, Connecting, 1).
Next steps
- See all 17 Zimmar Consulting , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNX, Zimmar Consulting , Ltd.'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.