Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Carter Products — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time

302 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K955672	TROJAN POLYURETHANE CONDOM (MODIFICATION)	Carter Products	1996-08-29	302
K942697	TROJAN POLYURETHANE CONDOM	Carter Products	1995-06-22	379
K912901	TROJAN (TM-TBD) CONDOM	Carter Products	1992-02-03	216
K904782	ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST	Carter Products	1990-12-06	45
K904273	MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.	Carter Products	1990-10-31	44
K901202	TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED	Carter Products	1990-06-19	99
K901199	TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED	Carter Products	1990-04-16	35
K901191	TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)	Carter Products	1990-04-16	35
K901190	TROJANS LATEX CONDOMS (MODIFIED LABELING)	Carter Products	1990-04-16	35
K901200	TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED	Carter Products	1990-04-16	35
K901198	TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED	Carter Products	1990-04-16	35
K901194	TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL	Carter Products	1990-04-16	35
K901193	TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)	Carter Products	1990-04-16	35
K901201	TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED	Carter Products	1990-04-16	35
K901197	TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL	Carter Products	1990-04-16	35
K901196	TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING	Carter Products	1990-04-16	35
K901192	TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)	Carter Products	1990-04-16	35
K901195	TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED	Carter Products	1990-04-16	35
K883413	TROJAN EXTRA STRENGTH LUBRICATED	Carter Products	1988-12-08	115
K882232	DISCOVER(R)	Carter Products	1988-10-25	151

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