510(k) Report

510(k) · Cleared

Cleared

Halyard ONE-STEP* Sterilization Wrap

K192147510(k) TraditionalCleared Oct 10, 201963-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

Owens & Minor (O&M) Halyard, Inc. · FRG Wrap, Sterilization

Cleared on Oct 10, 2019 as substantially equivalent to K141712 (Halyard Health, 2014) after a 63-day review. Its family tree reaches back 5 generations to 1988. 4 later devices descend from it.

Decided
Oct 10, 2019
Review
63 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K881471 (1988). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.

  1. Root · 5 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
  2. 4 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
  3. 3 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
  4. 2 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
  5. 1 generation backK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
  6. This deviceK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
  7. Descendant · cites it directly · 3 of its ownK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
  8. Descendant · 2 generations on · 2 of its ownK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
  9. Descendant · 3 generations on · 0 of its ownK261897 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology…O&M Halyard, Inc. · 2026
  10. Descendant · 3 generations on · 0 of its ownK253454 HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK*…O&M Halyard, Inc. · 2026

Most influential descendants

Showing 4 of 4 · See all
  • K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2022 · cites it directly3descendants
  • K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc. · 2024 · 2 generations on2descendants
  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc. · 2026 · 3 generations on0descendants
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K881471Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp.19881
−4K082177Kimguard One-Step Sterilization WrapKimberly-Clark Corp.2009—
−3K091685Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC…Kimberly-Clark Corp.2009—
−2K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp.2012—
−1K141712Kimguard One Step Sterilization WrapHalyard Health2014—
0 (this device)K192147Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc.2019—
+1K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc.2022—
+2K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization…O&M Halyard, Inc.2024—
+3K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc.2026—
+3K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization…O&M Halyard, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202410
202620
FIG. 1 — Lineage of K192147, 1988–2026Source: 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 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. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K141712Kimguard One Step Sterilization Wrap
Summary page 4
…ilizat ion Wra pWrap· K14 17- 12 K141712 Device Description Device Description: : Ha lya ONE-STEP• Halyard ONE…
Halyard Health2014—

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20223

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 31 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K214007 (Owens & Minor (O&M) Halyard, Inc., 2022) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
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

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC…

Read the full statement (277 words)

The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below:

Lumen Cycle:

Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:

Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:

≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long;

and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load).

Flexible Cycle:

Reusable rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;

Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long.

(Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K192147: Halyard ONE-STEP* Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192147

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