510(k) Report

510(k) · Cleared

Cleared

Tencel Topical Wound Dressing/Surgical Sponge

K921227510(k) TraditionalCleared May 29, 199277-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

Courtaulds Fibers, Inc. · NAB Gauze / Sponge,Nonresorbable For External Use

Cleared on May 29, 1992 after a 77-day review. The FDA summary names no predicate by number.

Decided
May 29, 1992
Review
77 days
Class
Class I
Product code
NAB
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K921227Source: FDA 510(k) database · 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), 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 NAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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?

The FDA summary names no predicate by number.

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.

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 Courtaulds Fibers, Inc.

3 FDA decisions under this applicant name. See the company

  • K972458Lyocell Wound Dressing/Surgical SpongeCourtaulds Fibers, Inc. · 1997
  • K932846Tencel X-Ray Detectable Sponges/Lap PadsCourtaulds Fibers, Inc. · 1993

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/K921227 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921227: Tencel Topical Wound Dressing/Surgical Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921227

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026