Shiley, Inc.: FDA filings under this applicant name
FDA lists 174 510(k) clearances under the applicant name “Shiley, Inc.” (first 1976, latest 1993), across 51 product codes in 6 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 21 | 21 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 14 | 14 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 13 | 13 |
| CAC | Apparatus, Autotransfusion | 11 | 11 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 11 | 11 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 | 10 |
| LFJ | Catheter, Subclavian | 7 | 7 |
| BTR | Tube, Tracheal (W/Wo Connector) | 5 | 5 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 5 | 5 |
| DXE | Catheter, Embolectomy | 5 | 5 |
Plus 41 more product codes.
Review panels
- Cardiovascular (129)
- Anesthesiology (28)
- Gastroenterology and Urology (8)
- Ear, Nose and Throat (3)
- General Hospital (3)
- General and Plastic Surgery (1)
Most recent Shiley, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920594 | SHILEY PERFUSION TUBING SETS | DTM | 1993-03-18 | 401 |
| K910991 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM | CAC | 1991-11-27 | 265 |
| K911876 | SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 | DTN | 1991-08-09 | 102 |
| K910923 | BCD ADVANCED | DTR | 1991-04-09 | 35 |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | CCC | 1991-01-14 | 286 |
| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | JOH | 1990-10-02 | 63 |
| K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. | DTZ | 1990-07-03 | 85 |
| K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR | DTZ | 1990-06-11 | 87 |
| K901249 | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR | DTZ | 1990-06-11 | 87 |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | DXS | 1990-05-10 | 79 |
164 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shiley, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shiley, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
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.
- Shiley Infusaid, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shiley, Inc.?
FDA lists 174 510(k) clearances under the applicant name “Shiley, Inc.” (first 1976, latest 1993), across 51 product codes in 6 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 Shiley, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shiley, Inc. is 60 days.
Which FDA product codes appear under Shiley, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 21); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 14); BTO (Tube, Tracheostomy (W/Wo Connector), 13).
Next steps
- See all 174 Shiley, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Shiley, 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.