510(k) Report

510(k) · Cleared

Cleared

D. R. Medical Controlled Pressure Garments

K001300510(k) TraditionalCleared Aug 30, 2000128-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

Confection Medicale D.R., Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on Aug 30, 2000 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 30, 2000
Review
128 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK001300 D. R. Medical Controlled Pressure GarmentsConfection Medicale D.R., Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK021102 DM SleeveEmily Iker M.D., A.P.C. · 2002
  3. Descendant · cites it directly · 1 of its ownK061411 Torbot Vascular Compression GarmentsTorbut Group, Inc. · 2006
  4. Descendant · 2 generations on · 0 of its ownK111662 Venotrain CuraflowBauerfeind AG · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K021102DM SleeveEmily Iker M.D., A.P.C. · 2002 · cites it directly2descendants
  • K061411Torbot Vascular Compression GarmentsTorbut Group, Inc. · 2006 · cites it directly1descendant
  • K111662Venotrain CuraflowBauerfeind AG · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001300D. R. Medical Controlled Pressure GarmentsConfection Medicale D.R., Inc.2000—
+1K021102DM SleeveEmily Iker M.D., A.P.C.2002—
+1K061411Torbot Vascular Compression GarmentsTorbut Group, Inc.2006—
+2K111662Venotrain CuraflowBauerfeind AG2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
201110
FIG. 1 — Lineage of K001300, 2000–2011Source: 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.

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  • 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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021102DM SleeveEmily Iker M.D., A.P.C.20022
K061411Torbot Vascular Compression GarmentsTorbut Group, Inc.20061

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, K021102 (Emily Iker M.D., A.P.C., 2002) has gone furthest, with 2 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—

Recent decisions in DWL

The DWL category page

  • K141127Medline Anti-Embolism StockingMedline Industries, Inc. · 2014
  • K131496Bellavar / Custom Seamless Soft (a.K.a. Comtesse)Bsn Medical, Inc. · 2013
  • K122485Encircle Compression Therapy StockingEncircle Medical Devices, Ltd. · 2013
  • K123820Bossong Hosiery Medical Compression Stockings 8-15 MMHG, Bossong Hosiery Anti-Embolism Stockings 10-20 MMHG…Bossong Hosiery Mills, Inc. · 2013
  • K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings; Futuro (TM) Travel…3M Company · 2012

https://510kreport.com/device/K001300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001300: D. R. Medical Controlled Pressure Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001300

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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