Invitrocare, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Invitrocare, Inc.” (first 2000, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| MQL | Media, Reproductive | 10 | 10 |
Review panels
Most recent Invitrocare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023222 | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 | MQL | 2002-12-26 | 90 |
| K003751 | HYALURONIDASE REAGENT, MODEL CAT#2212 | MQL | 2001-01-17 | 43 |
| K001967 | PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 | MQL | 2000-08-14 | 47 |
| K001113 | IVC THREE BLASTOCYST MEDIUM, CAT # 2007 | MQL | 2000-06-13 | 68 |
| K000989 | SPERM WASH MEDIUM, CAT# 2003/2005 | MQL | 2000-06-08 | 72 |
| K993484 | Q-HTF, CAT# 2001 | MQL | 2000-05-25 | 224 |
| K000938 | IVC ONE MEDIUM | MQL | 2000-05-25 | 63 |
| K000937 | IVC TWO MEDIUM | MQL | 2000-05-25 | 63 |
| K000940 | HUMAN SERUM ALBUMIN (HSA) | MQL | 2000-05-04 | 42 |
| K000939 | HTF-HEPES | MQL | 2000-05-04 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Invitrocare, 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 Invitrocare, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Invitrocare, Inc.” (first 2000, latest 2002), 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 Invitrocare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invitrocare, Inc. is 63 days.
Which FDA product codes appear under Invitrocare, Inc.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 10).
Next steps
- See all 10 Invitrocare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQL, Invitrocare, 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.