Tiger Medical Products, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tiger Medical Products, Ltd.” (first 2005, latest 2016), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 124 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 | 2 | 107 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 182 |
| 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
- General Hospital (4)
- Anesthesiology (1)
- Cardiovascular (1)
Most recent Tiger Medical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152947 | Disposable Temporary Pacing Cable | DSA | 2016-04-05 | 182 |
| K122717 | FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK | FXX | 2012-12-21 | 107 |
| K120690 | INSULIN PEN NEEDLE | FMI | 2012-06-22 | 107 |
| K110697 | TIGER SYRINGES AND NEEDLES | FMF | 2011-07-14 | 122 |
| K102713 | TIGER FLAT SURGICAL MASK | FXX | 2011-01-25 | 127 |
| K041311 | TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) | BTR | 2005-03-18 | 305 |
Recalls
openFDA lists no recalls under a recalling firm named Tiger Medical Products, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tiger Electronics, Inc. (1 510(k)s)
- Tiger Marketing, Inc. (1 510(k)s)
- Tiger Meditech Incorporated (1 510(k)s)
- Tiger Aesthetics Medical, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tiger Medical Products, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Tiger Medical Products, Ltd.” (first 2005, latest 2016), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tiger Medical Products, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tiger Medical Products, Ltd. is 124 days.
Which FDA product codes appear under Tiger Medical Products, Ltd.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 2); BTR (Tube, Tracheal (W/Wo Connector), 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Next steps
- See all 6 Tiger Medical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Tiger Medical Products, Ltd.'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.