510(k) · Cleared
ClearedDisposable Medical Safety Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hantech Medical Device Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 23, 2022 as substantially equivalent to K191644 (Anhui Tiankang Medical Technology Co., Ltd., 2020) after a 174-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Aug 23, 2022
- Review
- 174 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904198 (1990). 24 ancestors in all, the oldest K771205 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 7 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 6 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 5 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 4 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 3 generations backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 2 generations backK142765 TM Safety NeedleThinkmed Medical Technology Co., Ltd. · 2015
- 1 generation backK191644 TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2020
- This deviceK220603 Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −7 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −6 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −5 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −4 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −3 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| −2 | K142765 | TM Safety Needle | Thinkmed Medical Technology Co., Ltd. | 2015 | — |
| −1 | K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2007 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K191644 | TK Safety NeedleSummary page 4…name: Hypodermic Single Lumen Needle Classification: Class II, 21 CFR 880.5570 Product Code: FMI Premarket Notification: K191644 Manufacturer: Anhui Tiankang Medical Technology Co., Ltd IV Device description The Disposable Medical Safety Hypo… | 2020 |
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?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 2 other devices also cite its predicate K191644.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220603: Disposable Medical Safety Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220603
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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