510(k) · Cleared
ClearedSterile Hypodermic Needles for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azur Medical Company, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 14, 2021 as substantially equivalent to K180417 (Berpu Medical Technology Co., Ltd., 2018) after a 174-day review. Its family tree reaches back 7 generations to 1990. 4 later devices descend from it.
- Decided
- Oct 14, 2021
- Review
- 174 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904198 (1990). 32 ancestors in all, the oldest K771205 (1977). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 6 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 5 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 4 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 3 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 2 generations backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 1 generation backK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018
- This deviceK211214 Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK223334 Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK252631 Profoject™ Disposable NeedleCMT Health PTE., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK233037 Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK231519 Revital CadyRevital Healthcare (Epz) Limited · 2023
Most influential descendants
Showing 4 of 4 · See all- K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 2022 · cites it directly1descendant
- K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd. · 2025 · cites it directly0descendants
- K233037Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd. · 2023 · 2 generations on0descendants
- K231519Revital CadyRevital Healthcare (Epz) Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −6 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −5 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −4 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −3 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −2 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| −1 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes… | Berpu Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | 2021 | — |
| +1 | K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022 | — |
| +1 | K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025 | — |
| +2 | K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | 2023 | — |
| +1 | K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Summary page 4…e: Hypodermic single lumen needle Classification: Class II, 21 CFR 880.5570 Product Code: FMI 510(K) Number: K180417 Manufacturer: Berpu Medical Technology Co., Ltd IV Device description The Sterile Hypodermic Need… | 2018 |
What descends from it? (4)
3 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 31 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K223334 (Zhejiang Kindly Medical Devices Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K180417.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211214: Sterile Hypodermic Needles for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211214
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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