Zander Medical Supplies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zander Medical Supplies, Inc.” (first 2000, latest 2005), across 1 product code in 1 review panel. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | 5 | 5 |
Review panels
Most recent Zander Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041952 | ZIVF-AIRE | MQG | 2005-09-08 | 415 |
| K011327 | DB1 EMBRYO FREEZE | MQG | 2002-08-15 | 471 |
| K002971 | MTG - MINITUB HEATED STAGE SYSTEMS | MQG | 2000-12-15 | 84 |
| K002961 | MINITUB MULTI-PURPOSE CASSETTES | MQG | 2000-11-21 | 60 |
| K003184 | RS BIOTECH GALAXY 'R' CO2 INCUBATOR | MQG | 2000-11-20 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Zander Medical Supplies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Zander Medical Supplies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Zander Medical Supplies, Inc.” (first 2000, latest 2005), across 1 product code 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 Zander Medical Supplies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zander Medical Supplies, Inc. is 84 days.
Which FDA product codes appear under Zander Medical Supplies, Inc.?
The most frequent FDA product codes under this applicant name are MQG (Accessory, Assisted Reproduction, 5).
Next steps
- See all 5 Zander Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQG, Zander Medical Supplies, 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 (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.