510(k) Report

510(k) · Cleared

Cleared

Bodygem, Model HB211

K010577510(k) TraditionalCleared Jan 10, 2002317-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 Jan 10, 2002 after a 317-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 10, 2002
Review
317 days
Class
Class II
Product code
BZL
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2020: 1 descendant cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK010577 Bodygem, Model HB211Healthetech, Inc. · 2002
  2. Descendant · cites it directly · 2 of its ownK021490 Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
  4. Descendant · 2 generations on · 0 of its ownK071533 Fitmate SeriesCosmed Srl · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K021490Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc. · 2003 · cites it directly2descendants
  • K190561NICU V'02Cosmed Nordic Aps · 2020 · 2 generations on0descendants
  • K071533Fitmate SeriesCosmed Srl · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010577Bodygem, Model HB211Healthetech, Inc.2002—
+1K021490Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc.2003—
+2K190561NICU V'02Cosmed Nordic Aps2020—
+2K071533Fitmate SeriesCosmed Srl2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
202010
FIG. 1 — Lineage of K010577, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021490Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc.20032

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.

What does this lineage say?

  • Of its descendants, K021490 (Korr Medical Technologies, Inc., 2003) has gone furthest, with 2 descendants of its own.

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—

More from Healthetech, Inc.

2 FDA decisions under this applicant name. See the company

  • K021605MedgemHealthetech, 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/K010577 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010577: Bodygem, Model HB211.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010577

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