510(k) Report

510(k) · Cleared

Cleared

United Skin Barrier

K770982510(k) TraditionalCleared Jul 15, 197745-day reviewClass I21 CFR 876.5900

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

Howmedica Corp. · EXE Protector, Ostomy

Cleared on Jul 15, 1977 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 15, 1977
Review
45 days
Class
Class I
Product code
EXE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770982Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EXE? 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?

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

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 EXE devices

EXE Protector, Ostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXE

FDA has decided no EXE device since 2007.

Median 510(k) review, days · EXE

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

Recalls per year · EXE

1in 2024

2019: 12024: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · EXE

319in 2025

2010: 12012: 12013: 2322014: 9532015: 5272016: 1962017: 362018: 2,1422019: 16,6472020: 8,6672021: 1,1442022: 5472023: 3602024: 2952025: 319
2007high 16,647 (2019) · low 0 (2007)2025

MAUDE reports naming product code EXE, 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—00
20080—00
20090—00
20100—01
20110—00
20120—01
20130—0232
20140—0953
20150—0527
20160—0196
20170—036
20180—02,142
20190—116,647
20200—08,667
20210—01,144
20220—0547
20230—0360
20240—1295
20250—0319
20260—0—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in EXE

The EXE category page

  • K904233Convatec Absorbent BandageConvatec, A Division of E.R. Squibb & Sons · 1991
  • K760927Stoma Shield AdapterRudolfo T. Sanchez · 1977

https://510kreport.com/device/K770982 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770982: United Skin Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770982

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026