510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

YI Xin Sterile Syringe for Single Use

K050999510(k) TraditionalCleared Sep 2, 2005135-day reviewClass II21 CFR 880.5860Recalls 3 (3 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jiangxi Sanxin (Eversincere) Medical Devices Group · FMF Syringe, Piston

Cleared on Sep 2, 2005 as substantially equivalent to K042102 (Jiangxi Sanxin (Eversincere) Medical Devices Group, 2005) after a 135-day review. Its family tree reaches back 1 generation to 2005. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.

Decided
Sep 2, 2005
Review
135 days
Class
Class II
Product code
FMF
Recalls
3 (3 Class I)
Predicates
1

Its longest line of descent runs back 1 generation to K042102 (2005). 3 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 1 descendant cleared2010: 1 descendant cleared2022: 1 descendant clearedK042102 · Yixin Safety Syringe · Jiangxi Sanxin (Eversincere) Medical Devices Group · 200520052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K042102 · Yixin Safety Syringe · Jiangxi Sanxin (Eversincere) Medical Devices Group · 20050
  1. Root · 1 generation backK042102 Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005
  2. This deviceK050999 YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005
  3. Descendant · cites it directly · 2 of its ownK081436 Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008
  4. Descendant · 2 generations on · 1 of its ownK101359 Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK222744 Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K081436Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008 · cites it directly2descendants
  • K101359Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010 · 2 generations on1descendant
  • K222744Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K042102Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group2005—
0 (this device)K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group2005—
+1K081436Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc.2008—
+2K101359Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc.20101
+3K222744Sol-M Luer Lock SyringeSol-Millennium Medical, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
202210
FIG. 1 — Lineage of K050999, 2005–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K042102Yixin Safety Syringe
Summary page 3
…Center for Devices and Radiological Health Enclosure K042102 YI XIN Safety syringe Attachment B5 Indication for Use 510(K…
Jiangxi Sanxin (Eversincere) Medical Devices Group2005—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081436Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc.20082

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 8, 2023Class IZ-0005-2024Device DesignThere is a potential for blood backfill leakage and foreign material.
Aug 8, 2023Class IZ-0006-2024Device DesignThere is a potential for blood backfill leakage and foreign material.
Aug 8, 2023Class IZ-0007-2024Device DesignThere is a potential for blood backfill leakage and foreign material.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K081436 (Inviro Medical Devices, Inc., 2008) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

Indications for use as stated in the FDA 510(k) statement.

More from Jiangxi Sanxin (Eversincere) Medical…

2 FDA decisions under this applicant name. See the company

  • K042102Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K050999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050999: YI Xin Sterile Syringe for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050999

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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