Portable Power Systems, Inc.: FDA clearances and approvals
Portable Power Systems, Inc. has 18 FDA 510(k) clearances (first 1992, latest 1997), across 10 product codes in 6 review panels. Median 510(k) review time: 197 days.
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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 4 | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 4 | 4 |
| DPS | Electrocardiograph | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FCO | Box, Battery, Rechargeable | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
Review panels
- Cardiovascular (8)
- Radiology (4)
- General Hospital (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Portable Power Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970234 | SEALED LEAD ACID BATTERY PACK | IZL | 1997-05-02 | 101 |
| K946080 | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | FCO | 1995-08-02 | 232 |
| K945043 | BATTERY PACK #PMX120-18A | IZL | 1995-01-20 | 98 |
| K934508 | BATTERY PACK# S1024NC | LDD | 1994-02-17 | 156 |
| K934439 | RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR | DPS | 1994-02-17 | 178 |
| K934015 | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB | LDD | 1994-02-17 | 184 |
| K933065 | BATTERY PACK# S1009LA | DPS | 1994-02-17 | 240 |
| K932823 | BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK | DXN | 1994-02-17 | 253 |
| K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S | BZD | 1994-02-17 | 330 |
| K931483 | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. | IZL | 1994-02-17 | 330 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Portable Power Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Portable Power Systems, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via FCO)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Portable Power Systems, Inc. have?
Portable Power Systems, Inc. has 18 FDA 510(k) clearances (first 1992, latest 1997), across 10 product codes in 6 review panels.
How long does FDA take to clear Portable Power Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Portable Power Systems, Inc.'s cleared 510(k)s is 197 days.
What devices does Portable Power Systems, Inc. make?
Its most frequent FDA product codes are IZL (System, X-Ray, Mobile, 4); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 4); DPS (Electrocardiograph, 2).
Has Portable Power Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Portable Power Systems, Inc. Related entities may recall under other names.
Next steps
- See all 18 Portable Power Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Portable Power Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.