510(k) Report

510(k) · Cleared

Cleared

Orthopedic Casting Tape Maxcast

K832237510(k) TraditionalCleared Aug 16, 198336-day reviewClass I21 CFR 890.3025

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

Cutter Laboratories, Inc. · ITG Bandage, Cast

Cleared on Aug 16, 1983 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 16, 1983
Review
36 days
Class
Class I
Product code
ITG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K832237Source: 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 ITG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 ITG devices

ITG Bandage, Cast: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITG

FDA has decided no ITG device since 2007.

Median 510(k) review, days · ITG

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

Recalls per year · ITG

No recall names ITG since 2007.

Adverse event reports per year · ITG

4in 2025

2007: 22008: 42009: 42010: 22011: 12012: 42013: 52014: 22015: 12016: 12017: 42018: 152019: 42020: 32021: 62022: 92023: 32024: 82025: 4
2007high 15 (2018) · low 1 (2011)2025

MAUDE reports naming product code ITG, 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—02
20080—04
20090—04
20100—02
20110—01
20120—04
20130—05
20140—02
20150—01
20160—01
20170—04
20180—015
20190—04
20200—03
20210—06
20220—09
20230—03
20240—08
20250—04
20260—0—

More from Cutter Laboratories, Inc.

39 FDA decisions under this applicant name. See the company

  • K861315Hyperbaric Penetration Extension SetCutter Laboratories, Inc. · 1986
  • K854106BaysilexCutter Laboratories, Inc. · 1986
  • K842324PerfourmCutter Laboratories, Inc. · 1984
  • K834106Intravenous Infusion ControllerCutter Laboratories, Inc. · 1984
  • K823214Dosimetric Release Program - Admin. SetCutter Laboratories, Inc. · 1983

Recent decisions in ITG

The ITG category page

  • K873111Conforma (TM) Plaster BandagesThe Kendal Co. · 1987
  • K862115Dekna Band KitDeknatel, Inc. · 1986
  • K842573T.P.G. Cast TapeThe Poly Group, Inc. · 1984
  • K840416HexceliteHexcel Medical · 1984
  • K833732Non Wetting Undercast PaddingAmerican Medical Disposable, Inc. · 1983

https://510kreport.com/device/K832237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K832237: Orthopedic Casting Tape Maxcast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832237

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