510(k) Report

510(k) · Cleared

Cleared

AD-Heal (TM) Wound Dressing

K881731510(k) TraditionalCleared Aug 31, 1988131-day reviewClass I21 CFR 878.4020

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

Nepera, Inc. · NAD Dressing, Wound, Occlusive

Cleared on Aug 31, 1988 after a 131-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
Aug 31, 1988
Review
131 days
Class
Class I
Product code
NAD
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK881731 AD-Heal (TM) Wound DressingNepera, Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK963585 Bladder Manager Pci 5000, Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K963585Bladder Manager Pci 5000, Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881731AD-Heal (TM) Wound DressingNepera, Inc.1988—
+1K963585Bladder Manager Pci 5000, Bladderscan Bvi 5000Diagnostic Ultrasound Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K881731, 1988–1996Source: 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.

Planning a device in NAD? 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 NAD device

  1. #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
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? (1)

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

NumberDeviceApplicantDecidedDescendants
K963585Bladder Manager Pci 5000, Bladderscan Bvi 5000Diagnostic Ultrasound 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, K963585 (Diagnostic Ultrasound Corp., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NAD devices

NAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NAD

1in 2011

2008: 22009: 12011: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAD

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

Recalls per year · NAD

1in 2025

2010: 12014: 12018: 62022: 12025: 1
2007high 6 (2018) · low 0 (2007)2026

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

Adverse event reports per year · NAD

2,619in 2025

2007: 12008: 82009: 92010: 302011: 92012: 32013: 152014: 632015: 2512016: 1062017: 1342018: 1,0292019: 5882020: 5,0352021: 4512022: 4032023: 1,6192024: 1,8042025: 2,619
2007high 5,035 (2020) · low 1 (2007)2025

MAUDE reports naming product code NAD, 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
20082—08
20091—09
20100—130
20111—09
20120—03
20130—015
20140—163
20150—0251
20160—0106
20170—0134
20180—61,029
20190—0588
20200—05,035
20210—0451
20220—1403
20230—01,619
20240—01,804
20250—12,619
20261—0—

Recent decisions in NAD

The NAD category page

  • K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2026
  • K102403Sam Chest Seal with Vavle; Sam Chest SealSam Medical Products · 20111 recall
  • K091133Aplion Topical Care SystemAplion Medical,Llc · 2009
  • K072560Envela (Hydrohesive Occlusive Dressing)Teikoku Pharma USA, Inc. · 2008
  • K080524Centurion Sorbaview OtcTri-State Hospital Supply Corp. · 2008

https://510kreport.com/device/K881731 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881731: AD-Heal (TM) Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881731

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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