510(k) Report

510(k) · Cleared

Cleared

Anti-EM/GP Stockings

K955138510(k) TraditionalCleared Dec 13, 199530-day reviewClass II21 CFR 880.5780

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

Jobst Institute, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on Dec 13, 1995 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Dec 13, 1995
Review
30 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2012: 1 descendant cleared2010: 2 descendants cleared2009: 2 descendants cleared2007: 1 descendant cleared2004: 2 descendants cleared1995200020052010201520202025
  1. This deviceK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
  2. Descendant · cites it directly · 8 of its ownK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
  3. Descendant · 2 generations on · 5 of its ownK040353 Flight SockSsl Americas, Inc. · 2004
  4. Descendant · 2 generations on · 4 of its ownK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
  5. Descendant · 2 generations on · 2 of its ownK062873 Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex…E.C.I. USA Corporation · 2007
  6. Descendant · 2 generations on · 1 of its ownK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22007: 12009: 22010: 22012: 1
2003high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K032325Jobst Travel SocksBsn-Jobst, Inc. · 2003 · cites it directly8descendants
  • K040353Flight SockSsl Americas, Inc. · 2004 · 2 generations on5descendants
  • K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc. · 2009 · 2 generations on4descendants
  • K062873Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth…E.C.I. USA Corporation · 2007 · 2 generations on2descendants
  • K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955138Anti-EM/GP StockingsJobst Institute, Inc.1995—
+1K032325Jobst Travel SocksBsn-Jobst, Inc.2003—
+2K040353Flight SockSsl Americas, Inc.2004—
+2K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc.2009—
+2K062873Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and…E.C.I. USA Corporation2007—
+2K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200710
200920
201020
201210
FIG. 1 — Lineage of K955138, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032325Jobst Travel SocksBsn-Jobst, Inc.20038

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032325 (Bsn-Jobst, Inc., 2003) has gone furthest, with 8 descendants of its own.

How does its category compare?

All DWL devices

DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWL

1in 2014

2007: 12009: 22010: 32011: 22012: 52013: 32014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWL

111in 2013

2010: 214 days median2012: 43 days median2013: 111 days median
2007high 214 (2010) · low 43 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWL

No recall names DWL since 2007.

Adverse event reports per year · DWL

2in 2025

2007: 12009: 32010: 72011: 42012: 102013: 42014: 22015: 12017: 42018: 22019: 12020: 32021: 22022: 12023: 22025: 2
2007high 10 (2012) · low 0 (2008)2025

MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20092—03
2010321407
20112—04
2012543010
2013311104
20141—02
20150—01
20160—00
20170—04
20180—02
20190—01
20200—03
20210—02
20220—01
20230—02
20240—00
20250—02
20260—0—
Cite this page

510(k) Report. “K955138: Anti-EM/GP Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955138

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026