510(k) · Cleared

Cleared

Stryker T4 Hytrel Zipper Toga

K040764510(k) SpecialCleared Apr 27, 200433-day reviewClass II21 CFR 878.4040

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

Cleared on Apr 27, 2004 as substantially equivalent to K944393 (Stryker Corp., 1995) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.

Decided: Apr 27, 2004
Review: 33 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K944393 (1995). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK944393 Stryker Steri-Shield Surgical ApparelStryker Corp. · 1995 · Recalled
This deviceK040764 Stryker T4 Hytrel Zipper TogaStryker Corp. · 2004
Descendant · cites it directly · 3 of its ownK063005 Stryker T6 Hoods and TogasStryker Instruments · 2007
Descendant · 2 generations on · 1 of its ownK073017 Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · Recalled
Descendant · 3 generations on · 0 of its ownK141095 Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014
Descendant · 2 generations on · 0 of its ownK140588 Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014
Descendant · cites it directly · 0 of its ownK070078 Stryker T4 Hytrel TogaStryker Instruments, Instruments Div. · 2007 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K063005Stryker T6 Hoods and TogasStryker Instruments · 2007 · cites it directly3descendants
K073017Stryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. · 2007 · 2 generations on1descendant
K141095Stryker Steri-Shield Flyte Hybrid TogasStryker Corporation · 2014 · 3 generations on0descendants
K140588Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensStryker Corporation · 2014 · 2 generations on0descendants
K070078Stryker T4 Hytrel TogaStryker Instruments, Instruments Div. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944393	Stryker Steri-Shield Surgical Apparel	Stryker Corp.	1995	2
0 (this device)	K040764	Stryker T4 Hytrel Zipper Toga	Stryker Corp.	2004	—
+1	K063005	Stryker T6 Hoods and Togas	Stryker Instruments	2007	—
+2	K073017	Stryker Stri-Shield Flyte Togas	Stryker Instruments, Instruments Div.	2007	1
+3	K141095	Stryker Steri-Shield Flyte Hybrid Togas	Stryker Corporation	2014	—
+2	K140588	Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens	Stryker Corporation	2014	—
+1	K070078	Stryker T4 Hytrel Toga	Stryker Instruments, Instruments Div.	2007	27

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	3	0
2014	2	0

FIG. 1 — Lineage of K040764, 1995–2014Source: 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 FYA? 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 FYA device

#1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K944393	Stryker Steri-Shield Surgical Apparel Summary page 1 …The Stryker T4 Hytrel Zipper Toga is equivalent to the zipper toga of the Stryker Steri-shield Personal Protection System (K944393, KOI 1755). The material used on the front and sleeves of the Stryker T4 Hytrel Zipper Toga was shown to b…	Stryker Corp.	1995	2
*	K011755	Stryker T4 Hytrel (R) Togas	Stryker Corp.	2001	—

Also cleared against K944393: 2 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K063005	Stryker T6 Hoods and Togas	Stryker Instruments	2007	3
K070078	Stryker T4 Hytrel Toga	Stryker Instruments, Instruments Div.	2007	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K063005 (Stryker Instruments, 2007) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K944393.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FYA

4in 2025

2007high 24 (2022) · low 2 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYA

210in 2025

2007high 275 (2015) · low 98 (2009)2026

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

Recalls per year · FYA

1in 2025

2007high 40 (2020) · low 0 (2008)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · FYA

14in 2025

2007high 98 (2018) · low 3 (2008)2025

MAUDE reports naming product code FYA, 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	6	110	2	8
2008	4	207	0	3
2009	6	98	0	18
2010	4	128	2	9
2011	8	141	0	16
2012	4	202	1	43
2013	2	—	0	71
2014	5	120	9 (9)	42
2015	3	275	0	59
2016	3	155	0	43
2017	4	111	0	66
2018	2	—	1	98
2019	5	105	0	38
2020	7	114	40	31
2021	17	163	11	15
2022	24	177	2	4
2023	12	190	1	12
2024	5	163	0	27
2025	4	210	1	14
2026	9	198	2	—

What is it indicated for?

The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040764 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040764: Stryker T4 Hytrel Zipper Toga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040764

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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