Tiara Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Tiara Medical Systems, Inc.” (first 1997, latest 2005), across 1 product code in 1 review panel. Median 510(k) review time under this name: 177 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 7 | 7 |
Review panels
- Anesthesiology (7)
Most recent Tiara Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051583 | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 | BZD | 2005-11-04 | 142 |
| K043382 | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 | BZD | 2005-01-19 | 41 |
| K034053 | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 | BZD | 2004-06-24 | 177 |
| K031935 | TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 | BZD | 2004-03-03 | 254 |
| K012207 | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 | BZD | 2001-07-23 | 7 |
| K992192 | AIRPILOTMASK, MODEL TMS-900 | BZD | 2000-05-12 | 318 |
| K964092 | TMS COMFORT SERIES NASAL CPAP MASK | BZD | 1997-07-31 | 293 |
Recalls
openFDA lists no recalls under a recalling firm named Tiara Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tiara Medical Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Tiara Medical Systems, Inc.” (first 1997, latest 2005), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tiara Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tiara Medical Systems, Inc. is 177 days.
Which FDA product codes appear under Tiara Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 7).
Next steps
- See all 7 Tiara Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Tiara Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.