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UScreen®

Model USSCup-5M · Instant Technologies, Inc. · DI 00817405021161

NFT — Test, Amphetamine, Over The Counter · Class II · 21 CFR 862.3100

NFW — Test, Cannabinoid, Over The Counter · Class II · 21 CFR 862.3870

NFY — Test, Cocaine And Cocaine Metabolites, Over The Counter · Class II · 21 CFR 862.3250

NGG — Test, Methamphetamine, Over The Counter · Class II · 21 CFR 862.3610

NGL — Test, Opiates, Over The Counter · Class II · 21 CFR 862.3650

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 (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.

11222026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2026-0502
2026-0602
This device (reports/month)Average device in NFT, NFW, NFY, NGG, NGL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K182701 — cites (transitively): K122809 (d1) — cited as predicate by K191841, K202567, K210327, K220685, K222667, K242077, K252550

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

Manufacturer compliance record — Instant Technologies, Inc.

Nothing in the loaded window.