510(k) Report

510(k) · Cleared

Cleared

Medgem

K021605510(k) SpecialCleared Jun 14, 200229-day reviewClass II21 CFR 868.1730

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

Healthetech, Inc. · BZL Computer, Oxygen-Uptake

Cleared on Jun 14, 2002 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jun 14, 2002
Review
29 days
Class
Class II
Product code
BZL
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K021605Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZL? 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 BZL device

  1. #1 K190561 NICU V'02score 2.4 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 BZL devices

BZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZL

2in 2020

2007: 22010: 12011: 12020: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZL

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

Recalls per year · BZL

No recall names BZL since 2007.

Adverse event reports per year · BZL

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code BZL, 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
20072—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20202—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Indications for use as stated in the FDA 510(k) statement.

More from Healthetech, Inc.

2 FDA decisions under this applicant name. See the company

  • K010577Bodygem, Model HB211Healthetech, Inc. · 2002

Recent decisions in BZL

The BZL category page

  • K200076Breezing MedTf Health Co. · 2020
  • K190561NICU V'02Cosmed Nordic Aps · 2020
  • K110810Anascient Breath MonitorInvoy Technologies, LLC · 2011
  • K093080Metaphor Metabolic MonitorTreymed, Inc. · 2010
  • K071533Fitmate SeriesCosmed Srl · 2007

https://510kreport.com/device/K021605 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021605: Medgem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021605

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026