510(k) · Cleared
ClearedCirculator 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 May 7, 2009 as substantially equivalent to K792354 (Circulator Boot Corp., 1980) and 4 other predicates after a 282-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 7, 2009
- Review
- 282 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K940264 (1995). 10 ancestors in all, the oldest K792354 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
- 2 generations backK020857 Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced…Vasomedical, Inc. · 2002
- 1 generation backK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- This deviceK082134 Circulator BootCirculator Boot Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| −2 | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External… | Vasomedical, Inc. | 2002 | — |
| −1 | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2002 | — |
| 0 (this device) | K082134 | Circulator Boot | Circulator Boot Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 10.8 · 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? (5)
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 1…this submission: Multicrus Boot. NAMES OF LEGALLY MARKETED DEVICES FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3): Circulator Boot - K792354 (1980) - End-diastolic therapy using Long rigid boots for treatment of leg vascular diseases and congestive heart failure Circul… | 1980 |
| * | K833627 | Circulator MinibootSummary page 1…: Circulator Boot - K792354 (1980) - End-diastolic therapy using Long rigid boots for treatment of leg vascular diseases and congestive heart failure Circulator Boot - K833627/A (1984) - Modification of end-diastolic therapy to limit area of treatment to specific area needing the therapy: the lower leg.… | 1984 |
| * | K971026 | The Circulator BootSummary page 1…K833627/A (1984) - Modification of end-diastolic therapy to limit area of treatment to specific area needing the therapy: the lower leg. The Miniboot. Circulator Boot - K971026 (1997) - Addition of computer in heart monitor to automate the function of the attending boot technician in continually adjusting… | 1997 |
| * | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…Summary page 2…pressions and a maximum reduction in afterload is produced to assist the heart. A nomogram allows therapy in cases of atrial fibrillation. Vasomedical and CardioMedics: K020857and K22107. Indications approved for the latter include ischemic heart disease, congestive heart failure, angina pectoris, myocard… | 2002 |
| * | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | 2002 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K792354.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
2008 Indications and Contraindications for the Circulator Boot Systems "Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat: Poor arterial flow in extremities associated with: · Ischemic ulcers · Rest pain or claudication (pain with walking) * Threatened gangrene * Insufficient blood supply at an amputation site · Persisting ischemia after embolectomy or…
Read the full statement (135 words)
2008 Indications and Contraindications for the Circulator Boot Systems
"Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat:
Poor arterial flow in extremities associated with:
· Ischemic ulcers
· Rest pain or claudication (pain with walking)
* Threatened gangrene
* Insufficient blood supply at an amputation site
· Persisting ischemia after embolectomy or bypass surgery
* Pre- and post-arterial reconstruction to improve runoff
Diabetes complicated by the above or other conditions possibly related to arterial insufficiency including:
· Nocturnal leg cramps
* Necrobiosis diabeticorum
Venous diseases (once risk of emboli minimized):
· Prophylaxis of deep vein thrombophlebitis
· Edema and induration associated with chronic venous stasis
· Venous stasis ulcers
Athletic injuries: "Charlie horses", pulled muscles, and edematous muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082134: 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/K082134
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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