510(k) · Cleared

Cleared

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

K253454510(k) TraditionalCleared May 18, 2026227-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

O&M Halyard, Inc. · FRG Wrap, Sterilization

Cleared on May 18, 2026 as substantially equivalent to K234050 (O&M Halyard, Inc., 2024) after a 227-day review. Its family tree reaches back 8 generations to 1988.

Decided: May 18, 2026
Review: 227 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 8 generations to K881471 (1988). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 8 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
7 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
6 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
5 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
4 generations backK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
3 generations backK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
2 generations backK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
1 generation backK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
This deviceK253454 HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK*…O&M Halyard, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K881471	Kimguard (Regular & Heavy Duty) Sterile Wrap	Kimberly-Clark Corp.	1988	1
−7	K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2009	—
−6	K091685	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC…	Kimberly-Clark Corp.	2009	—
−5	K112805	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2012	—
−4	K141712	Kimguard One Step Sterilization Wrap	Halyard Health	2014	—
−3	K192147	Halyard ONE-STEP* Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	2019	—
−2	K214007	HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	2022	—
−1	K234050	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization…	O&M Halyard, Inc.	2024	—
0 (this device)	K253454	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization…	O&M Halyard, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K253454, 1988–2026Source: 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 FRG? 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 FRG device

#1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K234050	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap… Summary page 17 …T-FOLD* Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization wrap (21 CFR 880.6850, Product Code FRG) Predicate Device: K234050 (HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Ster…	O&M Halyard, Inc.	2024	—
†	K240330	HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap…	O&M Halyard, Inc.	2024	—
†	K214007	HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	2022	—
†	K192147	Halyard ONE-STEP* Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	2019	—
†	K181959	HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)	Owens & Minor Halyard, Inc.	2019	—
†	K143053	KIMGUARD ONE-STEP Sterilization Wrap	Kimberly-Clark Health Care	2015	—
†	K142782	KIMGUARD ONE-STEP Sterilization Wrap	Kimberly-Clark Health Care	2015	—
†	K141712	Kimguard One Step Sterilization Wrap	Halyard Health	2014	—
†	K140963	Kimguard Smart-Fold Sterilization Wrap	Kimberly-Clark Corp.	2014	—
†	K141612	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	2014	—
†	K141071	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	2014	—
†	K113806	Kimguard One Step Sterilization Wrap	Kimberly-Clark Health Care	2013	—
†	K112805	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2012	—
†	K112300	Kimguard Smart-Fold* Sterilization Wrap	Kimberly-Clark Corp.	2012	—
†	K092167	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600	Kimberly-Clark Corp.	2009	—
†	K091685	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600	Kimberly-Clark Corp.	2009	—
†	K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2009	—
†	K172191	STERIZONE VP4 Sterilizer	Tso3, Inc.	2018	—

Also cleared against K234050: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 38 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
1 of the 9 ancestors has a recall of any class.
1 other device also cites its predicate K234050.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, 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	182	0	1
2008	2	—	0	2
2009	4	171	0	2
2010	4	213	0	0
2011	6	110	0	12
2012	10	133	0	4
2013	6	146	2	5
2014	8	177	0	13
2015	12	196	0	9
2016	9	131	0	20
2017	9	260	29	7
2018	5	150	0	22
2019	9	258	0	10
2020	5	122	14	21
2021	4	170	0	9
2022	9	217	2	4
2023	9	230	0	13
2024	11	182	0	21
2025	9	151	0	18
2026	4	247	0	—

What is it indicated for?

Indication for Use (QUICK CHECK, ONE-STEP and SEQUENTIAL): HALYARD ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: • Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. • 100% ethylene oxide (EO) with a concentration of…

Read the full statement (480 words)

Indication for Use (QUICK CHECK, ONE-STEP and SEQUENTIAL):

HALYARD ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to

enclose another medical device that is to be sterilized by a healthcare provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes

for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600.

• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative

humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at

55°C or 12 hours at 43.3°C.

• STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively

aerated during the pre-programmed cycles.

• STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• STERIS V-PRO® 1 (Lumen Cycle)

• STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycles)

• STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycles)

• STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycles)

• Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 300 and 30

minute dry time for Models 400, 500, and 600)

• Advanced Sterilization Products STERRAD® Sterilization System

• STERRAD® 50, 100S, and 200

• STERRAD® NX®, (Standard Cycle, Advanced Cycle)

• STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)

• STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)

• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle,

DUO Cycle)

• STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles)

• Stryker Sterizone® VP4 Sterilizer Cycle 1

Indication For Use (SMART-FOLD):

HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical

device that is to be sterilized by a healthcare provider using:

- Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes.

- 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative

humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at

131°F/55°C or 12 hours at 110°F/43.3°C.

STERIS V-PRO® Low Temperature Sterilization Systems.

• STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• STERIS® V-PRO® 1 (Lumen Cycle)

• STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

- Advanced Sterilization Products STERRAD® Sterilization System

• STERRAD® 100S

• STERRAD® NX®, (Standard Cycle, Advanced Cycle)

• STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)

• STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI

Cycle)

• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle,

DUO Cycle, ULTRA GI Cycle)

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/K253454 · printed Nov 4, 2026

Cite this page

510(k) Report. “K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253454

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026