510(k) · Cleared

Cleared

MS Paed-Baby Body

K023796510(k) SpecialCleared Mar 3, 2003110-day reviewClass II21 CFR 868.1750

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

Erich Jaeger GmbH · CCM Plethysmograph, Pressure

Cleared on Mar 3, 2003 as substantially equivalent to K853390 (Erich Jaeger, Inc., 1986) after a 110-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Mar 3, 2003
Review: 110 days
Class: Class II
Product code: CCM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K853390 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK853390 Infant Body TestErich Jaeger, Inc. · 1986
This deviceK023796 MS Paed-Baby BodyErich Jaeger GmbH · 2003
Descendant · cites it directly · 0 of its ownK081823 Masterscreen Paed - Baby BodyViasys Healthcare GmbH · 2009

Most influential descendants

Showing 1 of 1 · See all

K081823Masterscreen Paed - Baby BodyViasys Healthcare GmbH · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K853390	Infant Body Test	Erich Jaeger, Inc.	1986	—
0 (this device)	K023796	MS Paed-Baby Body	Erich Jaeger GmbH	2003	—
+1	K081823	Masterscreen Paed - Baby Body	Viasys Healthcare GmbH	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K023796, 1986–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCM? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K853390	Infant Body Test Summary page 1 …ED - BABY BODY is an Erich Jaeger GmbH device classified under 73 CCM, “Plethysmograph, Pressure”, per Regulation No. 868.1750. Predicate Device: INFANT BODY TEST (K853390) Intended Use: The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is…	Erich Jaeger, Inc.	1986	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K081823	Masterscreen Paed - Baby Body	Viasys Healthcare GmbH	2009	0

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?

Its one ancestor has no recall.
Of its descendants, K081823 (Viasys Healthcare GmbH, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CCM devices

CCM Plethysmograph, Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCM

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCM

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

Recalls per year · CCM

No recall names CCM since 2007.

Adverse event reports per year · CCM

1in 2023

2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code CCM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	1
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	3
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The MS PAED - BABY BODY is a neonatal lung function measurement system that

utilizes a bodyplethysmograph. It is intended to be used under the direction of a

physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or

hospital. Patient population that may benefit from the use of this device include only

babies and premature infants.

The MS PAED - BABY BODY, or any of the accessories supplied with it, is not to be

used, alone or in combination, as a life support device, a life support system, or as a

critical component in a life support device or life support system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023796: MS Paed-Baby Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023796

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026