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Medline

Model MPHD141A3C · MEDLINE INDUSTRIES, INC. · DI 20193489017554

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

UDILibrary device dossier · generated 2026-09-15 · 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 (2)

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.

Malfunction: 2

11222026-05: 0 reports for this device; peer average 2/device2026-06: 2 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
2026-0622
This device (reports/month)Average device in NFT (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 — MEDLINE INDUSTRIES, INC.

  • Warning Letter 2026-03-26 MedLine Industries, LP (NAMIC Division)
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2020-06-11 Centurion Medical Products, LP
  • Warning Letter 2014-11-07 Excelsior Medical LLC
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • OAI 2025-12-12 MedLine Industries, LP (NAMIC Division) · 5 citations
  • NAI 2025-04-22 MICROTEK MEDICAL LLC · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-02-10 Centurion Medical Products, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • NAI 2022-04-05 Centurion Medical Products, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • OAI 2019-11-01 Centurion Medical Products, LP · 5 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • OAI 2019-08-20 Centurion Medical Products, LP · 5 citations