FDA product code PPS: Sleeve, Head And Neck, Compressible
PPS is the FDA product code for sleeve, head and neck, compressible. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under PPS. The average 510(k) review took 302 days (median 302).
Definition
Intended to move excess fluid from the target area to another area of the body.
Classification
| Field | Value |
|---|---|
| Device name | Sleeve, Head And Neck, Compressible |
| Device class | Class II |
| Regulation | 21 CFR 870.5800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PPS clearance
Top PPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tactile Systems Technology, Inc. (Dba Tactile Medical) | 1 | 2016-09-14 |
Most recent PPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153311 | Tactile Systems Technology, Inc. (Dba Tactile Medical) | Flexitouch System | 2016-09-14 | 302 |
Recalls for PPS devices
openFDA lists no recalls for product code PPS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G2190 — Patients with clinical indications for imaging of the head: headache radiating to the neck
Frequently asked questions
What is FDA product code PPS?
PPS is the FDA product code for sleeve, head and neck, compressible. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel.
What device class is PPS?
Class II, regulation 21 CFR 870.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code PPS?
Across 1 cleared submissions the average was 302 days from receipt to decision (median 302).
Which companies have the most PPS clearances?
Tactile Systems Technology, Inc. (Dba Tactile Medical) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PPS
- Run a recall and safety report across every PPS manufacturer
- Watch product code PPS 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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