510(k) · Cleared
ClearedSafe Block Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artsana S.P.A · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 10, 2016 as substantially equivalent to K051783 (Artsana S.P.A, 2005) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 1995. 11 later devices descend from it.
- Decided
- Feb 10, 2016
- Review
- 268 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951254 (1995). 4 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 1 generation backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
- This deviceK151311 Safe Block Pen NeedleArtsana S.P.A · 2016
- Descendant · cites it directly · 9 of its ownK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK210059 Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK193422 Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK191853 Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK261829 Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017 · cites it directly9descendants
- K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on1descendant
- K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021 · 2 generations on1descendant
- K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2019 · 2 generations on1descendant
- K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951254 | Safetyglide Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 4 |
| −1 | K050106 | Novofine Autocover 30G X 8MM | Novo Nordisk, Inc. | 2005 | — |
| 0 (this device) | K151311 | Safe Block Pen Needle | Artsana S.P.A | 2016 | — |
| +1 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| +2 | K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | Sandstone Medical (Suzhou), Inc. | 2021 | — |
| +2 | K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| +1 | K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K051783 | Artsana Pen Needles, Artsana Injection NeedlesSummary page 5…510(k) # Clearance Date Artsana Hypodermic Artsana S.p.A. K051783 2005.10.04 needles, Artsana Insupen insulin pen needle Novo Fine Auto Cover Novo Nordisk K050106… | 2005 |
| * | K050106 | Novofine Autocover 30G X 8MMSummary page 5…Artsana S.p.A. K051783 2005.10.04 needles, Artsana Insupen insulin pen needle Novo Fine Auto Cover Novo Nordisk K050106 2005.03.30 Inc Technological characteristics and comparison Artsana Safe Bl… | 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 21 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K161950 (Promisemed Hangzhou Meditech Co., Ltd., 2017) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K051783.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle.
The shield also serves to conceal the needle before and after injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151311: Safe Block 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/K151311
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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