Medical device manufacturer
Physio-Control, Inc.
Physio-Control, Inc. holds 94 FDA 510(k) clearances across 27 product codes. Median elapsed review time is 88 days. openFDA lists 72 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 27
- Median review
- 88 days
- Recall records
- 72
How does FDA spell Physio-Control, Inc.?
FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| PHYSIO-CONTROL, INC. | device/registrationlisting | normalised |
| Physio Control, Inc. | device/recall | normalised |
| Physio Control, Inc. | device/enforcement | normalised |
| Physio-Control Corp. | device/510k | normalised |
| Physio-Control Inc | device/enforcement | normalised |
| Physio-Control Inc | device/recall | normalised |
| Physio-Control, Inc. | device/enforcement | normalised |
| Physio-Control, Inc. | device/recall | normalised |
Showing 8 of 9.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Physio-Control, Inc. file in?
27 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 18 | 116 days | |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 17 | 132 days | |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 10 | 93 days | |
| DPS | Electrocardiograph | 5 | 64 days | |
| DRX | Electrode, Electrocardiograph | 5 | 9 days | |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 | 21 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 104 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 105 days | |
| DSF | Recorder, Paper Chart | 3 | 71 days | |
| IOL | Treadmill, Powered | 2 | 24 days | |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 2 | 12 days | |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 70 days | |
| MSX | System, Network And Communication, Physiological Monitors | 2 | 21 days | |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 | 15 days | |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 105 days | |
| DQA | Oximeter | 1 | 151 days | |
| DRL | Tester, Defibrillator | 1 | 25 days | |
| DRW | Adaptor, Lead Switching, Electrocardiograph | 1 | 14 days | |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 102 days | |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 45 days | |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 144 days | |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 57 days | |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 122 days | |
| GYE | Encephalogram Telemetry System | 1 | 39 days | |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 | 147 days |
Showing the 25 they file in most, of 27.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Physio-Control, Inc. had a recall?
openFDA lists 72 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2065-2026Class IIOpen, ClassifiedMKJ
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Z-1544-2026Class IIOpen, ClassifiedMKJ
Due to pediatric defibrillator electrode delamination
Z-2497-2025Class IIOpen, ClassifiedMKJ
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2498-2025Class IIOpen, ClassifiedMKJ
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2499-2025Class IIOpen, ClassifiedMKJ
Due to required inspections not being performed on products/units that have gone through servicing.
Showing the 5 most recently initiated of 72.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Physio-Control, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | MPD | 20 | |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | DSA | 102 | |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | LDD | 264 | |
| K142430 | LIFEPAK 15 monitor/defibrillator | MKJ | 112 | |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | MKJ | 180 | |
| K123597 | TRUECPR COACHING DEVICE | LIX | 147 | |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | MKJ | 45 | |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | 106 | |
| K102972 | LIFEPAK 12 | MKJ | 77 | |
| K102757 | LIFENET SYSTEM | MSX | 43 |
Source: openFDA device/510k · retrieved
Where is Physio-Control, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Physio-Control, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.