510(k) Report

510(k) · Cleared

Cleared

Torbot Vascular Compression Garments

K061411510(k) TraditionalCleared Oct 18, 2006149-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

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

Cleared on Oct 18, 2006 as substantially equivalent to K925154 (Jobst Institute, Inc., 1994) and 5 other predicates after a 149-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.

Decided
Oct 18, 2006
Review
149 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K963573 (1996). 6 ancestors in all, the oldest K925154 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1994: 1 other ancestor2011: 1 descendant clearedK963573 · Elvarex · Jobst A Beiersdorf Co. · 1996K021102 · DM Sleeve · Emily Iker M.D., A.P.C. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K021102 · DM Sleeve · Emily Iker M.D., A.P.C. · 2002K963573 · Elvarex · Jobst A Beiersdorf Co. · 19960
  1. Root · 2 generations backK963573 ElvarexJobst A Beiersdorf Co. · 1996
  2. 1 generation backK021102 DM SleeveEmily Iker M.D., A.P.C. · 2002
  3. This deviceK061411 Torbot Vascular Compression GarmentsTorbut Group, Inc. · 2006
  4. Descendant · cites it directly · 0 of its ownK111662 Venotrain CuraflowBauerfeind AG · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K111662Venotrain CuraflowBauerfeind AG · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963573ElvarexJobst A Beiersdorf Co.1996—
−1K021102DM SleeveEmily Iker M.D., A.P.C.2002—
0 (this device)K061411Torbot Vascular Compression GarmentsTorbut Group, Inc.2006—
+1K111662Venotrain CuraflowBauerfeind AG2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199910
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K061411, 1996–2011Source: 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), the FDA summary (predicates and indications), 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K925154Jobst-Custom
Summary page 1
…g ILL Predicate Devices Torbot Vascular Compression Garments are substantially equivalent to the following devices: * Jobst Custom Compression Garments K925154 * Jobst Elvarex Compression Garments K963573 * Jobst Ready-To-Wear Arm Sleeves K991570 * DR. Medical Control…
Jobst Institute, Inc.1994—
*K963573Elvarex
Summary page 1
…ssion Garments are substantially equivalent to the following devices: * Jobst Custom Compression Garments K925154 * Jobst Elvarex Compression Garments K963573 * Jobst Ready-To-Wear Arm Sleeves K991570 * DR. Medical Controlled Pressure Garments K001300 * Dr. Emily Ike…
Jobst A Beiersdorf Co.1996—
*K991570Jobst Ready-to-Wear Arm Sleeves
Summary page 1
…e following devices: * Jobst Custom Compression Garments K925154 * Jobst Elvarex Compression Garments K963573 * Jobst Ready-To-Wear Arm Sleeves K991570 * DR. Medical Controlled Pressure Garments K001300 * Dr. Emily Iker's DM Sleeve K021102 • Jobst Ready-To-Wea…
Beiersdorf-Jobt, Inc.1999—
*K001300D. R. Medical Controlled Pressure Garments
Summary page 1
…n Garments K925154 * Jobst Elvarex Compression Garments K963573 * Jobst Ready-To-Wear Arm Sleeves K991570 * DR. Medical Controlled Pressure Garments K001300 * Dr. Emily Iker's DM Sleeve K021102 • Jobst Ready-To-Wear Gauntlet K013852…
Confection Medicale D.R., Inc.2000—
*K021102DM Sleeve
Summary page 1
…mpression Garments K963573 * Jobst Ready-To-Wear Arm Sleeves K991570 * DR. Medical Controlled Pressure Garments K001300 * Dr. Emily Iker's DM Sleeve K021102 • Jobst Ready-To-Wear Gauntlet K013852 Page 1 of 2 IV. Description…
Emily Iker M.D., A.P.C.2002—
*K013852Jobst Ready-to-Wear Gauntlet
Summary page 1
…y-To-Wear Arm Sleeves K991570 * DR. Medical Controlled Pressure Garments K001300 * Dr. Emily Iker's DM Sleeve K021102 • Jobst Ready-To-Wear Gauntlet K013852 Page 1 of 2 IV. Description of the Device Torbot Vascular Compress…
Bsn-Jobst, Inc.2002—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K111662Venotrain CuraflowBauerfeind AG20110

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?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K111662 (Bauerfeind AG, 2011) has gone furthest, with 0 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—

What is it indicated for?

Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.

Indications for use as stated in the FDA summary.

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/K061411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061411: Torbot Vascular Compression Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061411

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026