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AirSculpt Air Hose (IN)

Model TD-10010 · Millennium Medical Technologies, Inc. · DI 00850000712461

QPB — System, Suction, Lipoplasty For Removal · Class II · 21 CFR 878.5040

UDILibrary device dossier · generated 2026-09-11 · 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.

11222020-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device0306080906100306
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2022-0601
2022-0801
2022-0901
2025-0602
2025-1002
2026-0302
2026-0601
This device (reports/month)Average device in QPB (reports/device/month)

Regulatory clearances

  • K241835 SESE 2024-11-27 (k number procode)

Predicate lineage

K241835 — cites (transitively): K010311 (d1)

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

Manufacturer compliance record — Millennium Medical Technologies, Inc.

  • NAI 2022-06-30 Millennium Medical Technologies Inc · 0 citations
  • VAI 2011-10-21 Millennium Medical Technologies Inc · 0 citations