Carter Products: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Carter Products” (first 1988, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| HIS | Condom | 15 | 15 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| MOL | Condom, Synthetic | 2 | 2 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
Review panels
Most recent Carter Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955672 | TROJAN POLYURETHANE CONDOM (MODIFICATION) | MOL | 1996-08-29 | 302 |
| K942697 | TROJAN POLYURETHANE CONDOM | MOL | 1995-06-22 | 379 |
| K912901 | TROJAN (TM-TBD) CONDOM | HIS | 1992-02-03 | 216 |
| K904782 | ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST | LCX | 1990-12-06 | 45 |
| K904273 | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. | LTZ | 1990-10-31 | 44 |
| K901202 | TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED | HIS | 1990-06-19 | 99 |
| K901201 | TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED | HIS | 1990-04-16 | 35 |
| K901200 | TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED | HIS | 1990-04-16 | 35 |
| K901199 | TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED | HIS | 1990-04-16 | 35 |
| K901198 | TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED | HIS | 1990-04-16 | 35 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carter Products.
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 Carter Products?
FDA lists 20 510(k) clearances under the applicant name “Carter Products” (first 1988, latest 1996), across 4 product codes in 2 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 Carter Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carter Products is 35 days.
Which FDA product codes appear under Carter Products?
The most frequent FDA product codes under this applicant name are HIS (Condom, 15); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); MOL (Condom, Synthetic, 2).
Next steps
- See all 20 Carter Products clearances with predicates and recalls
- Run predicate analysis for product code HIS, Carter Products'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.