510(k) Report

510(k) · Cleared

Cleared

Non-Absorbable Gauze, Surgical Sponge & Dressing

K891101510(k) TraditionalCleared Apr 17, 198946-day reviewClass I21 CFR 878.4014

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

Smith & Nephew United, Inc. · NAB Gauze / Sponge,Nonresorbable For External Use

Cleared on Apr 17, 1989 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 17, 1989
Review
46 days
Class
Class I
Product code
NAB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK891101 Non-Absorbable Gauze, Surgical Sponge & DressingSmith & Nephew United, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK960621 Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K960621Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891101Non-Absorbable Gauze, Surgical Sponge & DressingSmith & Nephew United, Inc.1989—
+1K960621Expandacell Instrument WipeShippert Medical Technologies Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K891101, 1989–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K960621Expandacell Instrument WipeShippert Medical Technologies Corp.19960

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?

  • Of its descendants, K960621 (Shippert Medical Technologies Corp., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NAB devices

NAB Gauze / Sponge,Nonresorbable For External Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NAB

FDA has decided no NAB device since 2007.

Median 510(k) review, days · NAB

Too few NAB 510(k)s in any year since 2007 to give a median.

Recalls per year · NAB

1in 2020

2018: 22020: 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · NAB

12in 2025

2007: 12008: 62009: 42010: 42011: 12012: 82013: 42014: 42015: 102016: 252017: 242018: 222019: 232020: 112021: 112022: 122023: 152024: 62025: 12
2007high 25 (2016) · low 1 (2007)2025

MAUDE reports naming product code NAB, 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
20070—01
20080—06
20090—04
20100—04
20110—01
20120—08
20130—04
20140—04
20150—010
20160—025
20170—024
20180—222
20190—023
20200—111
20210—011
20220—012
20230—015
20240—06
20250—012
20260—0—

More from Smith & Nephew United, Inc.

34 FDA decisions under this applicant name. See the company

  • K963096Allevyn Hydro Poly Dressing ND All Trac DressingSmith & Nephew United, Inc. · 1996
  • K961775Profore Four-Layer Bandage System KitSmith & Nephew United, Inc. · 1996
  • K945330Allevyn AdhesiveSmith & Nephew United, Inc. · 1995
  • K943619Cavi-Care Conforming Foam DressingSmith & Nephew United, Inc. · 1994
  • K942748IntrasiteSmith & Nephew United, Inc. · 1994

Recent decisions in NAB

The NAB category page

  • K946015Ivalon External SpongeIvalon · 1995
  • K940755Isolyer (4X4, 8PLY)Isolyer Co. · 1994
  • K931610Omnisorb II, Nonwoven Sponge, Sterile and NonOmni Mfg., Inc. · 1993
  • K925590Multi-Trauma DressingGam Industries, Inc. · 1993
  • K926072K-Band and K-CrepeParema, Ltd. · 1993

https://510kreport.com/device/K891101 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891101: Non-Absorbable Gauze, Surgical Sponge & Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891101

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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