510(k) · Cleared
ClearedTop Fine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daejin Tech Medical Manufacturing Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Mar 2, 2007 as substantially equivalent to K033575 (B.Braun Medical, Inc., 2004) and 2 other predicates after a 106-day review. Its family tree reaches back 2 generations to 1997. 11 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K973899 (1997). 6 ancestors in all, the oldest K955235 (1996). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 1 generation backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- This deviceK063466 Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
- Descendant · cites it directly · 9 of its ownK100812 Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- Descendant · 2 generations on · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014
- Descendant · 3 generations on · 1 of its ownK210748 Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK152877 SureFine Pen NeedleShina Med Corporation · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100812Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010 · cites it directly9descendants
- K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · 2 generations on4descendants
- K133100Carefine Pen NeedleFacet Technologies · 2014 · 2 generations on3descendants
- K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022 · 3 generations on1descendant
- K152877SureFine Pen NeedleShina Med Corporation · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −1 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| 0 (this device) | K063466 | Top Fine | Daejin Tech Medical Manufacturing Co., Ltd. | 2007 | — |
| +1 | K100812 | Ulticare Disposable Pen Needles | Ultimed, Inc. | 2010 | — |
| +2 | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| +2 | K133100 | Carefine Pen Needle | Facet Technologies | 2014 | — |
| +3 | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | 2022 | — |
| +3 | K152877 | SureFine Pen Needle | Shina Med Corporation | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033575 | One.Click NeedleSummary page 1…5570 Class of device: Class II. 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Multiple: B.Braun "one.clickTM needle", K033575, Terumo® Micro tapered Pen Needle K052561, BD Pen Needles K051899 3. Description of device: Top Fine® insulin pen needle… | 2004 |
| * | K052561 | Terumo Micro Tapered Pen NeedleSummary page 1…legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Multiple: B.Braun "one.clickTM needle", K033575, Terumo® Micro tapered Pen Needle K052561, BD Pen Needles K051899 3. Description of device: Top Fine® insulin pen needle consists of a sterile cap, a needle cap, a… | 2005 |
| * | K051899 | BD Pen NeedleSummary page 1…to which we are claiming equivalence [807.92(a)(3)] : Multiple: B.Braun "one.clickTM needle", K033575, Terumo® Micro tapered Pen Needle K052561, BD Pen Needles K051899 3. Description of device: Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which ho… | 2005 |
What descends from it? (11)
See all 112 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 10 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K100812 (Ultimed, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K033575.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063466 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063466: Top Fine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063466
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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