510(k) · Cleared

Cleared

Medipack See-Through Seal Sterilization Pouch

K993764510(k) TraditionalCleared Dec 16, 199938-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

Medipack Medical Packaging Mfg. Co. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Dec 16, 1999 as substantially equivalent to K990567 (Global Healthcare, Inc., 1999) after a 38-day review. Its family tree reaches back 1 generation to 1999. 30 later devices descend from it.

Decided: Dec 16, 1999
Review: 38 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990567 (1999). 30 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
This deviceK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
Descendant · cites it directly · 29 of its ownK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
Descendant · 2 generations on · 19 of its ownK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
Descendant · 2 generations on · 16 of its ownK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
Descendant · cites it directly · 7 of its ownK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
Descendant · 2 generations on · 6 of its ownK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005high 6 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 30 · See all

K051242Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005 · cites it directly29descendants
K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007 · 2 generations on19descendants
K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011 · 2 generations on16descendants
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 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990567	Global Healthcare Self-Sealing Sterilization Pouch	Global Healthcare, Inc.	1999	—
0 (this device)	K993764	Medipack See-Through Seal Sterilization Pouch	Medipack Medical Packaging Mfg. Co.	1999	—
+1	K051242	Winner Self Seal Sterilization Pouch	Winner Medical (Usa), Inc.	2005	—
+2	K070428	Medicom Self-Sealing Sterilization Pouch	A.R. Medicom, Inc.	2007	—
+2	K102158	Sigma Sterilization Pouch & Roll	Sigma Medical Supplies Corp.	2011	—
+1	K062704	Sterilization Pouch with Indicators	Winner Industries (Shenzhen) Co., Ltd.	2007	—
+2	K112591	Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process…	Safe Secure Packaging Co., Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2011	2	0
2012	1	0
2015	2	0
2016	2	0
2017	2	0
2018	2	0
2019	4	0
2021	2	0
2022	1	0
2023	1	0
2024	1	0
2025	6	0
2026	1	0

FIG. 1 — Lineage of K993764, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K990567	Global Healthcare Self-Sealing Sterilization Pouch Summary page 2 …PREDICATE DEVICE: The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is substantially equivalent to the Global Healthcare Sel_f-_Seqlin%) (Séegr;lé(z)%tégn Pouch (K990567) and the Defend Self-Sealing Sterilization Pouch COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the The MEDIPACK® SEE-THROUG…	Global Healthcare, Inc.	1999	—
*	—	Defend Self-Sealing Sterilization Pouch Named without a submission number			—

Also cleared against K990567: 2 other devices →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K051242	Winner Self Seal Sterilization Pouch	Winner Medical (Usa), Inc.	2005	29
K062704	Sterilization Pouch with Indicators	Winner Industries (Shenzhen) Co., Ltd.	2007	7

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?

Its one ancestor has no recall.
Of its descendants, K051242 (Winner Medical (Usa), Inc., 2005) has gone furthest, with 29 descendants of its own.
2 other devices also cite its predicate K990567.

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

2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007high 236 (2012) · low 89 (2009)2026

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

Recalls per year · KCT

17in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	199	0	2
2008	6	182	0	8
2009	6	89	0	5
2010	12	202	1	3
2011	6	117	2	3
2012	10	236	0	2
2013	8	131	1	6
2014	11	169	1	5
2015	15	151	0	6
2016	12	182	3	16
2017	10	211	1	3
2018	15	192	0	22
2019	18	187	0	15
2020	14	134	0	66
2021	18	185	1	26
2022	11	137	17	8
2023	10	94	0	30
2024	8	106	0	18
2025	11	205	0	50
2026	9	122	0	—

What is it indicated for?

The MEDIPACK® SEE-THROUGH 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993764: Medipack See-Through 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/K993764

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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