510(k) Report

510(k) · Cleared

Recalled · 2009

Sureone Insulin Syringe, 31 Gauge X 5/16

K021197510(k) SpecialCleared Apr 26, 200210-day reviewClass II21 CFR 880.5860Recalls 10

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

Hosuk Co., Ltd. · FMF Syringe, Piston

Cleared on Apr 26, 2002 as substantially equivalent to K002921 (Hosuk Co., Ltd., 2000) and 1 other predicate after a 10-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 10 times.

Decided
Apr 26, 2002
Review
10 days
Class
Class II
Product code
FMF
Recalls
10
Predicates
2

Its longest line of descent runs back 1 generation to K002921 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK002921 · Sureone Insulin Syringe · Hosuk Co., Ltd. · 2000 · recalled200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K002921 · Sureone Insulin Syringe · Hosuk Co., Ltd. · 2000 · recalled0
  1. Root · 1 generation backK002921 Sureone Insulin SyringeHosuk Co., Ltd. · 2000 · Recalled
  2. This deviceK021197 Sureone Insulin Syringe, 31 Gauge X 5/16Hosuk Co., Ltd. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002921Sureone Insulin SyringeHosuk Co., Ltd.20003
0 (this device)K021197Sureone Insulin Syringe, 31 Gauge X 5/16Hosuk Co., Ltd.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K021197, 2000–2002Source: 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 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002921Sureone Insulin Syringe
Summary page 1
…evices The sureone Insulin Syringe is substantially equivalent in intended use, function and composition to the currently marketed sureone Disposable Insulin Syringes, +K002921, and to NovoFine® 31 GA needles, K002403. Device Description The sureone disposable insulin syringe is used for subcutaneous inj…
Hosuk Co., Ltd.20003
*K002403Novofine 31 Disposable Needle
Summary page 1
…stantially equivalent in intended use, function and composition to the currently marketed sureone Disposable Insulin Syringes, +K002921, and to NovoFine® 31 GA needles, K002403. Device Description The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is…
Novo Norodisk Pharmaceuticals, Inc.2000—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 27, 2009Not classifiedZ-0573-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0576-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0570-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0571-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0574-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0575-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0569-2010OtherNeedles are becoming dislodged from the barrels.
Oct 27, 2009Not classifiedZ-0572-2010OtherNeedles are becoming dislodged from the barrels
Aug 21, 2009Not classifiedZ-2247-2009Nonconforming Material/ComponentNeedles separate from the barrels of the syringes
Aug 21, 2009Not classifiedZ-2248-2009Nonconforming Material/ComponentNeedles separate from the barrels of the syringes

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.

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?

Insulin syringes are intended only for the injection of U-100 insulin.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Hosuk Co., Ltd.

2 FDA decisions under this applicant name. See the company

  • K002921Sureone Insulin SyringeHosuk Co., Ltd. · 20003 recalls

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/K021197 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021197: Sureone Insulin Syringe, 31 Gauge X 5/16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021197

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