510(k) · Cleared
ClearedTruform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression Gauntlet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Appliance Industries, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Apr 27, 2012 as substantially equivalent to K013852 (Bsn-Jobst, Inc., 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 27, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991570 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK991570 Jobst Ready-to-Wear Arm SleevesBeiersdorf-Jobt, Inc. · 1999
- This deviceK121106 Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear…Surgical Appliance Industries, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991570 | Jobst Ready-to-Wear Arm Sleeves | Beiersdorf-Jobt, Inc. | 1999 | — |
| 0 (this device) | K121106 | Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression… | Surgical Appliance Industries, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013852 | Jobst Ready-to-Wear GauntletSummary page 1…PREDICATE DEVICE 807.92(a)(3) Legally Marketed Equivalent Device 51010# Product Manufacturer K013852 iobst Ready-To-Wear Gauntlet BSN-Jobst, Inc. K991570 Jobst Ready-To-Wear Sleeve BSN-J… | 2002 |
| * | K991570 | Jobst Ready-to-Wear Arm SleevesSummary page 1…rketed Equivalent Device 51010# Product Manufacturer K013852 iobst Ready-To-Wear Gauntlet BSN-Jobst, Inc. K991570 Jobst Ready-To-Wear Sleeve BSN-Jobst, Inc. DEVICE DESCRIPTION 807.92(… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K013852.
How does its category compare?
All DWL devicesDWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DWL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DWL
111in 2013
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
MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 3 | 214 | 0 | 7 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 5 | 43 | 0 | 10 |
| 2013 | 3 | 111 | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TRUFORMO Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and IsIndicated for use Inthe management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations.
The TRUWoRM Ready-To-Wear Compression Gauntlet is Intended to be used to apply pressure tothe hand and wrist and is indicated for use Inthe management of Lymphedema and other edema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121106: Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression Gauntlet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121106
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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