510(k) · Cleared

Recalled · Class II · 2013

Kimguard (Regular & Heavy Duty) Sterile Wrap

K881471510(k) TraditionalCleared Aug 10, 1988125-day reviewClass II21 CFR 880.6850Recalls 1

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

Kimberly-Clark Corp. · FRG Wrap, Sterilization

Cleared on Aug 10, 1988 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it. It has been recalled once.

Decided: Aug 10, 1988
Review: 125 days
Class: Class II
Product code: FRG
Recalls: 1
Predicates: 0

47 later devices descend from it, 2 citing it directly.

This deviceK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988
Descendant · cites it directly · 44 of its ownK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
Descendant · 2 generations on · 35 of its ownK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
Descendant · 2 generations on · 32 of its ownK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
Descendant · 2 generations on · 18 of its ownK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
Descendant · 2 generations on · 11 of its ownK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2009high 7 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 47 · See all

K082177Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009 · cites it directly44descendants
K092167Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600Kimberly-Clark Corp. · 2009 · 2 generations on35descendants
K091685Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600Kimberly-Clark Corp. · 2009 · 2 generations on32descendants
K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012 · 2 generations on18descendants
K112211Dura Blue Sterilization WrapCardinal Health200, LLC · 2011 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K881471	Kimguard (Regular & Heavy Duty) Sterile Wrap	Kimberly-Clark Corp.	1988	—
+1	K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2009	—
+2	K092167	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400…	Kimberly-Clark Corp.	2009	—
+2	K091685	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC…	Kimberly-Clark Corp.	2009	—
+2	K112805	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2012	—
+2	K112211	Dura Blue Sterilization Wrap	Cardinal Health200, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	4	0
2011	2	0
2012	7	0
2013	5	0
2014	4	0
2015	4	0
2016	1	0
2017	2	0
2018	1	0
2019	3	0
2022	3	0
2023	3	0
2024	6	0
2026	2	0

FIG. 1 — Lineage of K881471, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2009	44
K082554	Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600	Kimberly-Clark Corp.	2009	10

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 6, 2013	Class II	Z-0995-2013	Component design/selection	Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K082177 (Kimberly-Clark Corp., 2009) has gone furthest, with 44 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.

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	—

https://510kreport.com/device/K881471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881471: Kimguard (Regular & Heavy Duty) Sterile Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881471

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026