Peripheral Systems Group: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Peripheral Systems Group” (first 1990, latest 1994), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 123 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| KOE | Dilator, Urethral | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (12)
- Radiology (4)
- Gastroenterology and Urology (1)
Most recent Peripheral Systems Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | ITX | 1994-06-10 | 123 |
| K934433 | VANTAGE DIALTAION CATHETER | LIT | 1993-12-09 | 87 |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | ITX | 1993-10-07 | 121 |
| K931327 | PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE | DQX | 1993-07-14 | 120 |
| K915554 | HI-TORQUE SPORT-T(TM) GUIDE WIRE | DQX | 1993-02-09 | 426 |
| K914979 | EDM(R) INFUSION CATHETER | KRA | 1992-09-16 | 315 |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | ITX | 1992-02-27 | 176 |
| K915168 | PROFLEX 5 | LIT | 1992-02-19 | 96 |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | KOE | 1991-12-27 | 144 |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | ITX | 1991-12-17 | 118 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Peripheral Systems Group.
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.
- Peripheral Ave (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Peripheral Systems Group?
FDA lists 17 510(k) clearances under the applicant name “Peripheral Systems Group” (first 1990, latest 1994), across 8 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 Peripheral Systems Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peripheral Systems Group is 123 days.
Which FDA product codes appear under Peripheral Systems Group?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); ITX (Transducer, Ultrasonic, Diagnostic, 4); DQO (Catheter, Intravascular, Diagnostic, 2).
Next steps
- See all 17 Peripheral Systems Group clearances with predicates and recalls
- Run predicate analysis for product code LIT, Peripheral Systems Group'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.