Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Peripheral Systems Group — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
315 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | Peripheral Systems Group | 1994-06-10 | 123 | 0 |
| K934433 | VANTAGE DIALTAION CATHETER | Peripheral Systems Group | 1993-12-09 | 87 | 0 |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | Peripheral Systems Group | 1993-10-07 | 121 | 0 |
| K931327 | PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE | Peripheral Systems Group | 1993-07-14 | 120 | 0 |
| K915554 | HI-TORQUE SPORT-T(TM) GUIDE WIRE | Peripheral Systems Group | 1993-02-09 | 426 | 0 |
| K914979 | EDM(R) INFUSION CATHETER | Peripheral Systems Group | 1992-09-16 | 315 | 0 |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | Peripheral Systems Group | 1992-02-27 | 176 | 0 |
| K915168 | PROFLEX 5 | Peripheral Systems Group | 1992-02-19 | 96 | 0 |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Peripheral Systems Group | 1991-12-27 | 144 | 0 |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | Peripheral Systems Group | 1991-12-17 | 118 | 0 |
| K904984 | ADVANCE 418(TM) | Peripheral Systems Group | 1991-04-12 | 161 | 0 |
| K904959 | PSG HEMOSTATIC CONTROL VALVE | Peripheral Systems Group | 1990-12-17 | 42 | 0 |
| K903625 | DOPPLER NEEDLE AND FLOW MONITOR | Peripheral Systems Group | 1990-11-07 | 89 | 1 |
| K895179 | ACCESSOR PERIPHERAL DILATING GUIDE WIRE | Peripheral Systems Group | 1990-02-28 | 202 | 0 |
| K894944 | BALLOON DILATATION CATHETER | Peripheral Systems Group | 1990-01-19 | 169 | 0 |
| K895146 | GUIDING CATHETER | Peripheral Systems Group | 1990-01-19 | 150 | 0 |
| K895932 | PSG(TM) EDM(TM) INFUSION CATHETER | Peripheral Systems Group | 1990-01-04 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda