LIFESTYLES
Model 3000 · SURETEX LIMITED - BRANCH · DI 00070907030004
HIS — Condom · Class II · 21 CFR 884.5300
MOL — Condom, Synthetic · Class II · 21 CFR 884.5300
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2022-06-23 | Z-1530-2022 | Class II | Open, Classified | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2020-05 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 2 |
| 2023-07 | 0 | 1 |
| 2024-12 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-11 | 0 | 1.67 |
Regulatory clearances
- K160399 SESE 2016-07-25 (k number procode)
Predicate lineage
K160399 — cites (transitively): K070800 (d1) — cited as predicate by K171172, K231908, K232470
K163107 — cites (transitively): K941258 (d1) — cited as predicate by K200672, K252521
K941258 — cited as predicate by K163107
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SURETEX LIMITED - BRANCH
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