510(k) Report

510(k) · Cleared

Cleared

Swisstek 2000(TM) Cast Removal System

K932653510(k) TraditionalCleared Jan 28, 1994240-day reviewClass I21 CFR 888.5960

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

Carapace, Inc. · LGH Instrument, Cast Removal, Ac-Powered

Cleared on Jan 28, 1994 after a 240-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 28, 1994
Review
240 days
Class
Class I
Product code
LGH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K932653Source: 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 LGH? 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 lists a 510(k) statement for it but has not posted the file, 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 LGH devices

LGH Instrument, Cast Removal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGH

FDA has decided no LGH device since 2007.

Median 510(k) review, days · LGH

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

Recalls per year · LGH

No recall names LGH since 2007.

Adverse event reports per year · LGH

5in 2025

2009: 12010: 62011: 232012: 62013: 122014: 42015: 42016: 22017: 12018: 82019: 22024: 22025: 5
2007high 23 (2011) · low 0 (2007)2025

MAUDE reports naming product code LGH, 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—01
20100—06
20110—023
20120—06
20130—012
20140—04
20150—04
20160—02
20170—01
20180—08
20190—02
20200—00
20210—00
20220—00
20230—00
20240—02
20250—05
20260—0—

More from Carapace, Inc.

22 FDA decisions under this applicant name. See the company

  • K931722Carapace Labor and Delivery SetsCarapace, Inc. · 1994
  • K931822Carapace Pelvic Exam TraysCarapace, Inc. · 1994
  • K931729I.V. Start KitCarapace, Inc. · 1994
  • K931820Carapace Stillwater Bowl SetCarapace, Inc. · 1994
  • K931669Carapace Debridement KitsCarapace, Inc. · 1994

Recent decisions in LGH

The LGH category page

  • K901677Carapace Portable Cast Saw, Swiss-EX Cast CutterBuckman Co., Inc. · 1990
  • K893380QCR System I and QCR System IIBremer Mfg. & Tool Co., Inc. · 1989
  • K895861Delta-Tech (TM) Cast Removal SystemJohnson & Johnson Professionals, Inc. · 1989
  • K873723Plaster Vacuum, 230V Model NO. 4183-161Martin Medical · 1987
  • K873721Plaster Vacuum, 115V Model NO. 4183-160Martin Medical · 1987

https://510kreport.com/device/K932653 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932653: Swisstek 2000(TM) Cast Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932653

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