510(k) · Cleared
ClearedHuntleigh Flowpress AC300 Pump, SQ301/302/320 Gar.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Technology, Inc. · DRM Compressor, Cardiac, External
Cleared on Sep 15, 1987 after a 168-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
- Sep 15, 1987
- Review
- 168 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK871271 Huntleigh Flowpress AC300 Pump, SQ301/302/320 Gar.Huntleigh Technology, Inc. · 1987
- Descendant · cites it directly · 2 of its ownK961292 WLP Sequential Version Model WLP Solo VI, WLP Solo SequentialWright Linear Pump, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK071040 Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK131387 Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K961292WLP Sequential Version Model WLP Solo VI, WLP Solo SequentialWright Linear Pump, Inc. · 1996 · cites it directly2descendants
- K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007 · 2 generations on1descendant
- K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871271 | Huntleigh Flowpress AC300 Pump, SQ301/302/320 Gar. | Huntleigh Technology, Inc. | 1987 | — |
| +1 | K961292 | WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential | Wright Linear Pump, Inc. | 1996 | — |
| +2 | K071040 | Wright Model 51 and 52 Sequential Compression Systems | Wright Linear Pump, Inc. | 2007 | — |
| +3 | K131387 | Wright Gradient 52 - Torso | Wright Therapy Products, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
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.
Planning a device in DRM? 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 DRM device
- #1 K221700 AutoPulse NXT Resuscitation Systemscore -7.5 · 6 generations · Class I recall
- #2 Held for the reportin the report
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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961292 | WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential | 1996 | 2 |
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, K961292 (Wright Linear Pump, Inc., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DRM
Too few DRM 510(k)s in any year since 2007 to give a median.
Recalls per year · DRM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRM
690in 2025
MAUDE reports naming product code DRM, 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 | 8 |
| 2008 | 2 | — | 1 | 13 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 1 | 483 |
| 2013 | 0 | — | 0 | 1,268 |
| 2014 | 1 | — | 0 | 664 |
| 2015 | 0 | — | 0 | 674 |
| 2016 | 2 | — | 0 | 639 |
| 2017 | 0 | — | 0 | 679 |
| 2018 | 1 | — | 0 | 783 |
| 2019 | 0 | — | 0 | 706 |
| 2020 | 0 | — | 0 | 844 |
| 2021 | 1 | — | 0 | 755 |
| 2022 | 0 | — | 1 | 730 |
| 2023 | 1 | — | 0 | 765 |
| 2024 | 0 | — | 0 | 710 |
| 2025 | 0 | — | 0 | 690 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K871271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871271: Huntleigh Flowpress AC300 Pump, SQ301/302/320 Gar..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871271
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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