510(k) · Cleared
ClearedThe Circulator Boot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circulator Boot Corp. · DRN Device, Counter-Pulsating, External
Cleared on Aug 14, 1997 as substantially equivalent to K792354 (Circulator Boot Corp., 1980) and 2 other predicates after a 147-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.
- Decided
- Aug 14, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K792354 (1980). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K082134Circulator BootCirculator Boot Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792354 | The Circulator Boot | Circulator Boot Corp. | 1980 | — |
| 0 (this device) | K971026 | The Circulator Boot | Circulator Boot Corp. | 1997 | — |
| +1 | K082134 | Circulator Boot | Circulator Boot Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 DRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRN device
- #1 K250756 Pression Wave PRO External Counter-Pulsation…score 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K792354 | The Circulator BootSummary page 4…f Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 471026 The Circulator Boot is equivalent to: 1. The Circulator Boot ( original model ) 510(k) # K792354 2. The Jobst Extremity Pump 3. Cardiassist 510(K) # K882683 510(K) # K792430 Product Device description Difference from Circ… | 1980 |
| * | K882683 | Jobst Extremity Pump (R) System 7500Summary page 4…Number 471026 The Circulator Boot is equivalent to: 1. The Circulator Boot ( original model ) 510(k) # K792354 2. The Jobst Extremity Pump 3. Cardiassist 510(K) # K882683 510(K) # K792430 Product Device description Difference from Circulator Boot Cardiassist Water pressure applied from groin Block… | 1988 |
| * | K792430 | Cardiassist External CounterpulsationSummary page 4…he Circulator Boot is equivalent to: 1. The Circulator Boot ( original model ) 510(k) # K792354 2. The Jobst Extremity Pump 3. Cardiassist 510(K) # K882683 510(K) # K792430 Product Device description Difference from Circulator Boot Cardiassist Water pressure applied from groin Blocks blood flow into… | 1980 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082134 | Circulator Boot | 2009 | 0 |
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?
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRN
Too few DRN 510(k)s in any year since 2007 to give a median.
Recalls per year · DRN
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRN
1in 2024
MAUDE reports naming product code DRN, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Circulator Boot System - alone or in combination with other drug or device therapies - may be used to treat:
peripheral arterial disease
ischemic lesions
claudication pain
necrotizing cellulitis
venous stasis ulcers
stasis dermatitis
chronic lymphedema
thrombophlebitis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971026: The Circulator Boot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971026
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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