510(k) · Cleared
ClearedSafira
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medovate Limited · FRN Pump, Infusion
Cleared on Oct 31, 2023 as substantially equivalent to K153599 (Concert Medical, LLC, 2016) after a 293-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Oct 31, 2023
- Review
- 293 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K800560 (1980). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK800560 MX820-5 Pressure Infusor 500CC MX820-10Medex, Inc. · 1980
- 3 generations backK973133 Big Bag 3000 Pressure InfusorByron Medical · 1997
- 2 generations backK980738 Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…Byron Medical · 1998
- 1 generation backK153599 Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
- This deviceK230083 SafiraMedovate Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K800560 | MX820-5 Pressure Infusor 500CC MX820-10 | Medex, Inc. | 1980 | — |
| −3 | K973133 | Big Bag 3000 Pressure Infusor | Byron Medical | 1997 | — |
| −2 | K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid… | Byron Medical | 1998 | — |
| −1 | K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016 | — |
| 0 (this device) | K230083 | Safira | Medovate Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K153599 | Concert Medical Hands-Free Syringe (HFS)Summary page 5…sification Name: Infusion Pump Device Regulation 21 CFR 880.5725 Device Classification Class II Predicate Device: Medovate Limited SAFIRA; K153599 Common/Usual Name: Infusion Pump Product Code: FRN Classification Name: Infusion Pump Device Regulatio… | 2016 |
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 43 years and passes through 4 companies; a new generation was cleared every 17.4 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230083: Safira.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230083
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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