510(k) · Cleared
ClearedGem Flow Now (GEM2770-FN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Micro Companies Alliance · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 28, 2024 as substantially equivalent to K143589 (Synovis Life Technologies, Inc., 2015) after a 117-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Jan 28, 2024
- Review
- 117 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K093310 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK093310 Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
- 3 generations backK132727 Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc. · 2013 · Recalled
- 2 generations backK142309 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2014
- 1 generation backK143589 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2015 · Recalled
- This deviceK233394 Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093310 | Gem Flow Coupler Device and System | Synovis Micro Companies Alliance, Inc. | 2010 | — |
| −3 | K132727 | Gem Flow Coupler Device and System | Synovis Life Technologies, Inc. | 2013 | 5 |
| −2 | K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2014 | — |
| −1 | K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015 | 2 |
| 0 (this device) | K233394 | Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance | 2024 | — |
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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K143589 | GEM Flow COUPLER Device and SystemSummary page 4…ppler, Ultrasonic Regulatory Class: Class 2 Regulation: 892.1550 Product Code: IYN, ITX III. Predicate Device GEM Flow Coupler Device and System K143589 (Reference device: Cook-Swartz Doppler Probe K171272) IV. Device Description The GEM FLOW NOW (FLOW NOW) device is compri… | 2015 |
| † | K171272 | Cook-Swartz Doppler Flow Probe | 2018 |
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 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K143589.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233394: Gem Flow Now (GEM2770-FN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233394
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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