510(k) · Cleared
ClearedSofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hlb Lifescience Co., Ltd. · FMF Syringe, Piston
Cleared on Dec 23, 2024 as substantially equivalent to K212635 (Hwajin Medical Co., Ltd., 2023) after a 179-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- Dec 23, 2024
- Review
- 179 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931367 (1993). 28 ancestors in all, the oldest K822083 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 7 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 6 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 5 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 4 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 3 generations backK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- 2 generations backK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
- 1 generation backK212635 SofjecHwajin Medical Co., Ltd. · 2023
- This deviceK241856 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK253112 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −7 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −6 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −5 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −4 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −3 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| −2 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile… | Shanghai Kohope Medical Devices Co., Ltd. | 2019 | — |
| −1 | K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023 | — |
| 0 (this device) | K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K212635 | SofjecSummary page 5…Subject Device Special 510(k) No. Predicate Device 510(k) No. Sofjec K241856 K212635 Device name and Classification name Trade Name: Sofjec (Single use Needle); Sofjec (Single use Syringe with or withou… | 2023 |
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 |
|---|---|---|---|
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec… | 2026 | 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 31 years and passes through 9 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K253112 (Hlb Lifescience Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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(108 model codes including Sofjec-16-13)
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13)
Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Membrane Filter Syringe (16 model codes including HJM-18-1)
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/K241856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241856
Report an extraction error
Are you the manufacturer?
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