510(k) · Cleared
ClearedSofjec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hwajin Medical Co., Ltd. · FMF Syringe, Piston
Cleared on Feb 13, 2023 as substantially equivalent to K190002 (Shanghai Kohope Medical Devices Co., Ltd., 2019) and 1 other predicate after a 543-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 13, 2023
- Review
- 543 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931367 (1993). 27 ancestors in all, the oldest K822083 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 6 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 5 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 4 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 3 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 2 generations backK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- 1 generation backK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
- This deviceK212635 SofjecHwajin Medical Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241856 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253112 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See all- K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2024 · cites it directly1descendant
- K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −6 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −5 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −4 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −3 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −2 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| −1 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile… | Shanghai Kohope Medical Devices Co., Ltd. | 2019 | — |
| 0 (this device) | K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023 | — |
| +1 | K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2024 | — |
| +2 | K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Summary page 5…4 7178 4. Identification of Predicate Device(s) The identified predicate devices within this submission are shown as follow: Predicate device ⚫ K190002 – Sterile Hypodermic Syringe for Single Use, with/without needle, Sterile Insulin Syringe for Single Use, Sterile H… | 2019 |
| * | K173743 | Greenmedi Safety Filter SyringeSummary page 5…rile Hypodermic Syringe for Single Use, with/without needle, Sterile Insulin Syringe for Single Use, Sterile Hypodermic needle for Single use ⚫ K173743 – Greenmedi Safety Filter Syringe 5.Description of the Device The device has three model with the following: ① Single use Need… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec… | 2024 | 1 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K241856 (Hlb Lifescience Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K190002.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
Single use Needle
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with Needle
Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Membrane Filter Syringe
Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212635: Sofjec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212635
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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