510(k) · Cleared
ClearedUlticare Disposable Pen Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultimed, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 3, 2010 as substantially equivalent to K002938 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2000) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 1997. 9 later devices descend from it.
- Decided
- Jun 3, 2010
- Review
- 72 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K973899 (1997). 7 ancestors in all, the oldest K955235 (1996). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 2 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 1 generation backK063466 Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
- This deviceK100812 Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- Descendant · cites it directly · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014
- Descendant · 2 generations on · 1 of its ownK210748 Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK152877 SureFine Pen NeedleShina Med Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK140568 Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · cites it directly4descendants
- K133100Carefine Pen NeedleFacet Technologies · 2014 · cites it directly3descendants
- K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022 · 2 generations on1descendant
- K152877SureFine Pen NeedleShina Med Corporation · 2016 · 2 generations on1descendant
- K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC · 2014 · 2 generations on1descendant
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 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −1 | K063466 | Top Fine | Daejin Tech Medical Manufacturing Co., Ltd. | 2007 | — |
| 0 (this device) | K100812 | Ulticare Disposable Pen Needles | Ultimed, Inc. | 2010 | — |
| +1 | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| +1 | K133100 | Carefine Pen Needle | Facet Technologies | 2014 | — |
| +2 | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | 2022 | — |
| +2 | K152877 | SureFine Pen Needle | Shina Med Corporation | 2016 | — |
| +2 | K140568 | Carefine Pen Needle with Quintapoint and Superpoint | Facet Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002938 | B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Summary page 1…Classification Name: Hypo'dermic single lumen needles (§880.5570) Product Codle: FMI fl?4Predicate Device(s): K002938: Becton Dickinson B-U Ultra-Fine"" III Pen Needle; Model 31 gauge x 3/1 6"… | 2000 |
| Kept off the family tree | K1031200 | Becton Dickinson B-D Ultra-Fine Original Pen Needles (29 gauge x 1/2") Number could not be read Summary page 1…K002938: Becton Dickinson B-U Ultra-Fine"" III Pen Needle; Model 31 gauge x 3/1 6" k K~~~~~~1031200: Becton Dickinson B-D Ultra-Finetm Original Pen Needles (29 gauge x 1/2")… | |
| * | K063466 | Top FineSummary page 1…K~~~~~~1031200: Becton Dickinson B-D Ultra-Finetm Original Pen Needles (29 gauge x 1/2") 1(063466: Daejin Tech Medical Manufacturing Co:, Ltd Top Fineeo Insulin Pen Needles (29 -32 gauge;… | 2007 |
What descends from it? (9)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K113186 (Shina Corp., 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K002938.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 UltiCare Disposable Pen Needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100812: Ulticare Disposable Pen Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100812
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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