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LIFESTYLES

Model 08859798106591 · SURETEX LIMITED - BRANCH · DI 08859798106591

MOL — Condom, Synthetic · Class II · 21 CFR 884.5300

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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.

11222022-11: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device110111
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-1101
2023-0102
2025-1101
This device (reports/month)Average device in MOL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K171172 — cites (transitively): K160399 (d1), K070800 (d2) — cited as predicate by K182438

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — SURETEX LIMITED - BRANCH

Nothing in the loaded window.