510(k) Report

FDA product code · Cardiovascular

Sleeve, Head And Neck, Compressible

PPSClass II21 CFR 870.5800510(k) required1 decision since 20160 recalls

1 FDA decision since 2016. No recall names this code. The most-cited predicate is K153311, named by 1 later device.

Intended to move excess fluid from the target area to another area of the body.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of PPS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PPS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PPS

Too few PPS 510(k)s in any year since 2007 to give a median.

Recalls per year · PPS

No recall names PPS since 2007.

Adverse event reports per year · PPS

No MAUDE report names PPS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PPS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PPS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PPS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 20161cites it

Which PPS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 20166generations

What has FDA decided in PPS lately?

  • K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016

The one PPS decision →

Related product codes

Other codes under 21 CFR 870.5800.

LHX Trousers, Anti-ShockJOW Sleeve, Limb, Compressible