510(k) · Cleared
ClearedFlowtron AC200/2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Technology, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Sep 23, 1988 after a 315-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Sep 23, 1988
- Review
- 315 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK874688 Flowtron AC200/2Huntleigh Technology, Inc. · 1988
- 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
- Descendant · cites it directly · 0 of its ownK961891 WLP Single-Segment Version WLP Solo ViiWright Linear Pump, Inc. · 1996
Most influential descendants
Showing 4 of 4 · 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
- K961891WLP Single-Segment Version WLP Solo ViiWright Linear Pump, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874688 | Flowtron AC200/2 | Huntleigh Technology, Inc. | 1988 | — |
| +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 | — |
| +1 | K961891 | WLP Single-Segment Version WLP Solo Vii | Wright Linear Pump, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 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 IRP? 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 IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
https://510kreport.com/device/K874688 · printed Nov 5, 2026
Cite this page
510(k) Report. “K874688: Flowtron AC200/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K874688
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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