Pioneering Technologies, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Pioneering Technologies, Inc.” (first 1988, latest 1992), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DXC | Clamp, Vascular | 2 | 2 |
| DNP | Thin Layer Chromatography, Ethosuximide | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
| DWP | Dilator, Vessel, Surgical | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (14)
- General and Plastic Surgery (2)
- General Hospital (1)
- Neurology (1)
- Clinical Toxicology (1)
Most recent Pioneering Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922025 | ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF | DSY | 1992-09-22 | 168 |
| K905175 | PTI ANNULOPLASTY RING(STERILE) | KRH | 1992-02-14 | 452 |
| K905068 | PTI INTRA-ART (TM) PICK-UP WICKS | EFQ | 1991-12-31 | 417 |
| K910067 | PTI STERNAL CLOSURE WIRE SUTURE | GAQ | 1991-05-06 | 117 |
| K905067 | PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT | DSY | 1991-03-18 | 129 |
| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | DRE | 1990-07-03 | 71 |
| K901682 | PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS | DSY | 1990-07-03 | 84 |
| K901531 | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE | DNP | 1990-06-20 | 90 |
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | GXY | 1990-05-02 | 29 |
| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | DXC | 1990-04-10 | 111 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pioneering Technologies, 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 Pioneering Technologies, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Pioneering Technologies, Inc.” (first 1988, latest 1992), across 13 product codes in 5 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 Pioneering Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pioneering Technologies, Inc. is 84 days.
Which FDA product codes appear under Pioneering Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 3); DWS (Instruments, Surgical, Cardiovascular, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2).
Next steps
- See all 19 Pioneering Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Pioneering Technologies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.