510(k) Report

FDA applicant

Tiara Medical Systems, Inc.

Lakewood, OH7 decisions1997–20050 recalls

FDA records 7 decisions for Tiara Medical Systems, Inc. (Lakewood, OH) from 1997 to 2005: 7 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Tiara Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tiara Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tiara Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tiara Medical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)7decisions

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012207Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530Tiara Medical Systems, Inc. · 20013cite it
  • K031935Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Tiara Medical Systems, Inc. · 20042cite it
  • K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 20051cites it
  • K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc. · 20041cites it

What has FDA decided for it lately?

  • K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030, TMS- 3040, TMS-3050Tiara Medical Systems, Inc. · 2005
  • K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
  • K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc. · 2004
  • K031935Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Tiara Medical Systems, Inc. · 2004
  • K012207Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530Tiara Medical Systems, Inc. · 2001
  • K992192Airpilotmask, Model TMS-900Tiara Medical Systems, Inc. · 2000
  • K964092TMS Comfort Series Nasal Cpap MaskTiara Medical Systems, Inc. · 1997

All 7 as Tiara Medical Systems, Inc. →