510(k) · Cleared
ClearedThe Red Head Collection Device, The Jordy Connection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miami Fat Supply · MUU System, Suction, Lipoplasty
Cleared on Feb 24, 2017 as substantially equivalent to K092284 (Medical Device Resource Corp., 2009) after a 283-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Feb 24, 2017
- Review
- 283 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K895761 (1989). 8 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK895761 General AsperatorKolster Methods · 1989
- 5 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 4 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 3 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 2 generations backK081593 Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008
- 1 generation backK092284 Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp. · 2009
- This deviceK161372 The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −5 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −4 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −3 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −2 | K081593 | Power Aspirator, Model LS2 or LS2DP | Medical Device Resource Corp. | 2008 | — |
| −1 | K092284 | Lipisystems Aquavage, Models AV2000 and AV1200 | Medical Device Resource Corp. | 2009 | — |
| 0 (this device) | K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 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 MUU? 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 MUU device
- #1 K210528 IntelliFat Disposable Adipose Tissue…score 5.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092284 | Lipisystems Aquavage, Models AV2000 and AV1200Summary page 4…Product Code KYZ Classification Panel: General and Plastic Surgery Common Name: Lipoplasty System Predicate Device: K092284 Lipisystems AquaVage (Product Code MUU) 21CFR 880.6960 Irrigatio… | 2009 |
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 28 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K092284.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUU
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MUU
190in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUU
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUU
10in 2025
MAUDE reports naming product code MUU, 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 | — | 1 | 2 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 3 | 113 | 0 | 2 |
| 2010 | 4 | 58 | 0 | 4 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 5 | 171 | 0 | 4 |
| 2013 | 1 | — | 0 | 21 |
| 2014 | 4 | 114 | 0 | 13 |
| 2015 | 3 | 269 | 1 | 44 |
| 2016 | 1 | — | 1 | 20 |
| 2017 | 7 | 91 | 2 | 28 |
| 2018 | 1 | — | 0 | 30 |
| 2019 | 4 | 190 | 0 | 35 |
| 2020 | 2 | — | 0 | 36 |
| 2021 | 2 | — | 0 | 28 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
Aspiration of adipose (fatty) tissue
Harvesting adipose (fatty) tissue
Filtering adipose (fatty) tissue
Extraction of autologous adipose (fatty) tissue
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/K161372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161372: The Red Head Collection Device, The Jordy Connection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161372
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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