510(k) · Cleared
ClearedDual-Safety Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 5, 2019 as substantially equivalent to K161950 (Promisemed Hangzhou Meditech Co., Ltd., 2017) after a 57-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Sep 5, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973899 (1997). 14 ancestors in all, the oldest K951254 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 6 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 5 generations backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- 4 generations backK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- 3 generations backK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- 2 generations backK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- 1 generation backK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- This deviceK191853 Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK202682 Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −6 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −5 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| −4 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| −3 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| −2 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| −1 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| 0 (this device) | K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| +1 | K202682 | Promisemed Triple Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 3 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleSummary page 4…21 CFR 807.92(a)(3) Predicate [510(k)] # Predicate Trade Name Product Code K161950 Verifine ® Safety Type Insulin Pen Needle FMI Device Description Summary… | 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 |
|---|---|---|---|
| K202682 | Promisemed Triple Safety Pen Needle | 2020 | 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 22 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K202682 (Promisemed Hangzhou Meditech Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K161950.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191853: Dual-Safety Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191853
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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