510(k) Report

510(k) · Cleared

Recalled · 2003

Triton

K801643510(k) TraditionalCleared Jul 28, 198011-day reviewClass I21 CFR 890.3750Recalls 2

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

Chattanooga Group, Inc. · INW Table, Mechanical

Cleared on Jul 28, 1980 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.

Decided
Jul 28, 1980
Review
11 days
Class
Class I
Product code
INW
Recalls
2
Predicates
0

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

FIG. 1 — Lineage of K801643Source: 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.

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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)

Recalls of this device

DateClassRecallRoot causeReason
May 30, 2003Not classifiedZ-1210-03OtherProduct contains an improper bracket for the transducer.
May 30, 2003Not classifiedZ-1215-03OtherProduct contains an improper bracket for the transducer.

No ancestor or descendant has a Class I recall.

How does its category compare?

All INW devices

INW Table, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · INW

FDA has decided no INW device since 2007.

Median 510(k) review, days · INW

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

Recalls per year · INW

No recall names INW since 2007.

Adverse event reports per year · INW

1in 2023

2008: 22009: 12010: 12018: 12022: 12023: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code INW, 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—02
20090—01
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—00
20260—0—

More from Chattanooga Group, Inc.

70 FDA decisions under this applicant name. See the company

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  • K982321Vectra Stim Models 200 and 400Chattanooga Group, Inc. · 1999
  • K982830Forte, Models CPS 400 Combo, CPS 200 ComboChattanooga Group, Inc. · 1998

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https://510kreport.com/device/K801643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K801643: Triton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801643

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