510(k) · Cleared
ClearedSafety Insulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 18, 2020 as substantially equivalent to K181447 (Berpu Medical Technology Co., Ltd., 2019) after a 145-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Feb 18, 2020
- Review
- 145 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K970737 (1997). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 7 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 6 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 5 generations backK102108 Clickfine Pen NeedleYpsomed AG · 2010
- 4 generations backK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- 3 generations backK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- 2 generations backK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- 1 generation backK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- This deviceK192677 Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 0 of its ownK221178 Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −7 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −6 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −5 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −4 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| −3 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| −2 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| −1 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K192677 | Safety Insulin Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +1 | K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K181447 | Safety insulin needle for single useSummary page 5…enance package which could maintain the sterility of the device during the shelf life of five years. 5. Identification of Predicate Device 510(k) Number: K181447 Trade/Device Name: Safety insulin needle for single use… | 2019 |
| † | K170846 | Disposable Insulin Pen Needle | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221178 | Disposable Insulin Pen Needle | 2022 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K221178 (Ningbo Medsun Medical Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181447.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192677: Safety Insulin Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192677
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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