510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

OXHClass II21 CFR 878.3300510(k) required5 decisions since 20150 recalls

5 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 140 days (half between 84 and 195). No recall names this code. The most-cited predicate is K202430, named by 3 later devices.

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.

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

FIG. A — Illustration, general and plastic surgery panel

Twenty years of OXH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OXH

1in 2025

2015: 12016: 12017: 12021: 12025: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXH

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

Recalls per year · OXH

No recall names OXH since 2007.

Adverse event reports per year · OXH

2in 2025

2016: 212017: 52018: 32020: 22025: 2
2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code OXH, 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—00
20110—00
20120—00
20130—00
20140—00
20151—00
20161—021
20171—05
20180—03
20190—00
20200—02
20211—00
20220—00
20230—00
20240—00
20251—02
20260—0—
FIG. 1 — OXH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OXH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OXH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K202430Kerecis ReconstructKerecis Limited · 20213cite it
  • K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 20151cites it

Which OXH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences) · 201710generations
  • K251844Kerecis SurgiBind (50241)Kerecis Limited · 20258generations
  • K202430Kerecis ReconstructKerecis Limited · 20217generations
  • K160400Miromatrix Biological MeshMiromatrix Medical, Inc. · 20165generations
  • K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 20154generations

What has FDA decided in OXH lately?

  • K251844Kerecis SurgiBind (50241)Kerecis Limited · 2025
  • K202430Kerecis ReconstructKerecis Limited · 2021
  • K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences) · 20172 recalls
  • K160400Miromatrix Biological MeshMiromatrix Medical, Inc. · 2016
  • K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 2015

All 5 OXH decisions →

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