510(k) · Cleared
ClearedUnifine SafeControl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford, Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 17, 2021 as substantially equivalent to K173881 (Owen Mumford, Ltd., 2018) after a 219-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 17, 2021
- Review
- 219 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973899 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 2 generations backK152339 Unifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd. · 2016 · Recalled
- 1 generation backK173881 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GOwen Mumford, Ltd. · 2018
- This deviceK210399 Unifine SafeControlOwen Mumford, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −2 | K152339 | Unifine Pentips/ Unifine Pentips Plus | Owen Mumford, Ltd. | 2016 | 3 |
| −1 | K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | Owen Mumford, Ltd. | 2018 | — |
| 0 (this device) | K210399 | Unifine SafeControl | Owen Mumford, Ltd. | 2021 | — |
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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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 |
|---|---|---|---|
| * | K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GSummary page 5…lation: 21 CFR 880.5570 Regulatory Class: II Product Code: FMI 3. Predicate Devices The predicate device, Unifine SafeControlTM by Owen Mumford Ltd, was approved under K173881. The new needle lengths and gauge sizes presented in this submission have not been previously submitted. 4. Description of The… | 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 24 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210399: Unifine SafeControl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210399
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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