FDA product code PEC: Sterilizer Automated Loading System
PEC is the FDA product code for sterilizer automated loading system. It is a Class II device, regulated under 21 CFR 880.6880 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under PEC. The average 510(k) review took 435 days (median 435).
Definition
Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer Automated Loading System |
| Device class | Class II |
| Regulation | 21 CFR 880.6880 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PEC clearance
Top PEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Getinge Sourcing, LLC | 1 | 2013-05-02 |
Most recent PEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120532 | Getinge Sourcing, LLC | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | 2013-05-02 | 435 |
Recalls for PEC devices
openFDA lists no recalls for product code PEC.
Frequently asked questions
What is FDA product code PEC?
PEC is the FDA product code for sterilizer automated loading system. It is a Class II device, regulated under 21 CFR 880.6880 and reviewed by the General Hospital panel.
What device class is PEC?
Class II, regulation 21 CFR 880.6880. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEC?
Across 1 cleared submissions the average was 435 days from receipt to decision (median 435).
Which companies have the most PEC clearances?
Getinge Sourcing, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PEC
- Run a recall and safety report across every PEC manufacturer
- Watch product code PEC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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