510(k) Report

510(k) · Cleared

Cleared

Winner Self Seal Sterilization Pouch

K051242510(k) TraditionalCleared Dec 13, 2005214-day reviewClass II21 CFR 880.6850

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

Winner Medical (Usa), Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Dec 13, 2005 as substantially equivalent to K993764 (Medipack Medical Packaging Mfg. Co., 1999) and 1 other predicate after a 214-day review. Its family tree reaches back 2 generations to 1999. 29 later devices descend from it.

Decided
Dec 13, 2005
Review
214 days
Class
Class II
Product code
KCT
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K990567 (1999). 29 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2011: 2 descendants cleared2012: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2017: 2 descendants cleared2015: 2 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2025: 6 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK990567 · Global Healthcare Self-Sealing Sterilization Pouch · Global Healthcare, Inc. · 1999K993764 · Medipack See-Through Seal Sterilization Pouch · Medipack Medical Packaging Mfg. Co. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 11 descendants4 generations forward: 5 descendants K993764 · Medipack See-Through Seal Sterilization Pouch · Medipack Medical Packaging Mfg. Co. · 1999K990567 · Global Healthcare Self-Sealing Sterilization Pouch · Global Healthcare, Inc. · 19990
  1. Root · 2 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
  2. 1 generation backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
  3. This deviceK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
  4. Descendant · cites it directly · 19 of its ownK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
  5. Descendant · cites it directly · 16 of its ownK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
  6. Descendant · cites it directly · 7 of its ownK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
  7. Descendant · cites it directly · 6 of its ownK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
  8. Descendant · 2 generations on · 5 of its ownK212338 SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2007: 22011: 22012: 12015: 22016: 22017: 22018: 22019: 42021: 22022: 12023: 12024: 12025: 62026: 1
2007high 6 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 29 · See all
  • K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007 · cites it directly19descendants
  • K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011 · cites it directly16descendants
  • K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007 · cites it directly7descendants
  • K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 2012 · cites it directly6descendants
  • K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K990567Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc.1999—
−1K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co.1999—
0 (this device)K051242Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc.2005—
+1K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc.2007—
+1K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp.2011—
+1K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd.2007—
+1K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process…Safe Secure Packaging Co., Ltd.2012—
+2K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201120
201210
201520
201620
201720
201820
201940
202120
202210
202310
202410
202560
202610
FIG. 1 — Lineage of K051242, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 KCT? 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 KCT device

  1. #1 K214041 Aesculap AICON Containerscore 18.1 · 6 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
*K993764Medipack See-Through Seal Sterilization Pouch
Summary page 1
…elf Seal Sterilization Pouch 3. Classification Name: Pack, Sterilization Wrapper, Bag and Accessories (21 CFR 880.6850). 4. Predicate Device: a. K993764 - Medipack® See-Through Self Seal Sterilization Pouch. b. K990567 - Global Healthcare Self-Sealing Sterilization Pouch.…
Medipack Medical Packaging Mfg. Co.1999—
*K990567Global Healthcare Self-Sealing Sterilization Pouch
Summary page 1
…Wrapper, Bag and Accessories (21 CFR 880.6850). 4. Predicate Device: a. K993764 - Medipack® See-Through Self Seal Sterilization Pouch. b. K990567 - Global Healthcare Self-Sealing Sterilization Pouch. Page 1 of 2 5. In…
Global Healthcare, Inc.1999—

Also cleared against K993764: 1 other device →

What descends from it? (29)

See all 29

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc.200719
K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp.201116
K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd.20077
K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.20126
K110867Steri-Dent, Steri-SureCpac, Inc.20110

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 6 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K070428 (A.R. Medicom, Inc., 2007) has gone furthest, with 19 descendants of its own.
  • 1 other device also cites its predicate K993764.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCT

11in 2025

2007: 32008: 62009: 62010: 122011: 62012: 102013: 82014: 112015: 152016: 122017: 102018: 152019: 182020: 142021: 182022: 112023: 102024: 82025: 112026 (partial year): 9
2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007: 199 days median2008: 182 days median2009: 89 days median2010: 202 days median2011: 117 days median2012: 236 days median2013: 131 days median2014: 169 days median2015: 151 days median2016: 182 days median2017: 211 days median2018: 192 days median2019: 187 days median2020: 134 days median2021: 185 days median2022: 137 days median2023: 94 days median2024: 106 days median2025: 205 days median2026 (partial year): 122 days median
2007high 236 (2012) · low 89 (2009)2026

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

Recalls per year · KCT

17in 2022

2010: 12011: 22013: 12014: 12016: 32017: 12021: 12022: 17
2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCT

50in 2025

2007: 22008: 82009: 52010: 32011: 32012: 22013: 62014: 52015: 62016: 162017: 32018: 222019: 152020: 662021: 262022: 82023: 302024: 182025: 50
2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, 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
2007319902
2008618208
200968905
20101220213
2011611723
20121023602
2013813116
20141116915
20151515106
201612182316
20171021113
201815192022
201918187015
202014134066
202118185126
202211137178
20231094030
20248106018
202511205050
202691220—

What is it indicated for?

Winner® Self Seal Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 1210C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Indications for use as stated in the FDA summary.

Also cleared against K993764

1 other device cites the same predicate.

  • K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007

Recent decisions in KCT

The KCT category page

  • K262084S.I.N. Instruments KitsS.I.N. Implant System Ltda · 2026
  • K262042Sterilization Cassette (CASS-1)Alliedstar Medical Equipment Co., Ltd. · 2026
  • K253988LiteSet TraysNobel Biocare AB · 2026
  • K261935Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
  • K253187SteriBest® Sterilization Tray SystemMastel Surgical · 2026

https://510kreport.com/device/K051242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051242: Winner Self Seal Sterilization Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051242

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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