# Tiara Medical Systems, Inc.

- Location (FDA's records): Lakewood, OH
- FDA decisions: 7 (1997–2005): 7 510(k) clearances
- Product codes: BZD (7)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Hans Rudolph, Inc.: 1 (https://510kreport.com/company/hans-rudolph)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Breathing Technologies Corp.: 1 (https://510kreport.com/company/breathing-technologies)
- Innomed Technologies: 1 (https://510kreport.com/company/innomed-technologies)
- Sensor Medics Corp.: 1 (https://510kreport.com/company/sensor-medics)

## Firms that cite its devices most
- Cardinal Health 207, Inc.: 2 (https://510kreport.com/company/cardinal-health-207)
- Sleepnet Corporation: 1 (https://510kreport.com/company/sleepnet)

## Its most-cited devices
- K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530 (2001), cited by 3
- K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 (2004), cited by 2
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (2005), cited by 1
- K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 (2004), cited by 1

## Recent decisions
- K051583: Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (Nov 4, 2005)
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (Jan 19, 2005)
- K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 (Jun 24, 2004)
- K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 (Mar 3, 2004)
- K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530 (Jul 23, 2001)
- K992192: Airpilotmask, Model TMS-900 (May 12, 2000)
- K964092: TMS Comfort Series Nasal Cpap Mask (Jul 31, 1997)

Source page: https://510kreport.com/company/tiara-medical-systems