510(k) · Cleared
ClearedSC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shinchang Medical Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 23, 2007 as substantially equivalent to K002938 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2000) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 23, 2007
- Review
- 139 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002938 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK002938 B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000
- This deviceK070988 SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G…Shinchang Medical Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002938 | B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000 | — |
| 0 (this device) | K070988 | SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) | Shinchang Medical Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K002938 | B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Summary page 2…equivalent in intended use, function and basic composition to the legally marketed Becton Dickinson B-D Ultra-fine III pen needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine original Pen Needle (29 gauge x 1/2"), K031200. E. Technological Charact… | 2000 |
| * | K031200 | Modification to BD Ultra-Fine Iii Pen NeedleSummary page 2…Dickinson B-D Ultra-fine III pen needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine original Pen Needle (29 gauge x 1/2"), K031200. E. Technological Characteristics The SC Profi Fine pen needles have similar technological characteristics to the… | 2003 |
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?
- None of the 2 ancestors has a recall.
- 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. 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 SC Profi Fine pen needle is intended for use 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/K070988 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070988: SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070988
Report an extraction error
Are you the manufacturer?
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