510(k) · Cleared

Cleared

Masterscreen Paed - Baby Body

K081823510(k) TraditionalCleared May 18, 2009325-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

Viasys Healthcare GmbH · CCM Plethysmograph, Pressure

Cleared on May 18, 2009 as substantially equivalent to K023796 (Erich Jaeger GmbH, 2003) and 2 other predicates after a 325-day review. Its family tree reaches back 2 generations to 1986.

Decided: May 18, 2009
Review: 325 days
Class: Class II
Product code: CCM
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K853390 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK853390 Infant Body TestErich Jaeger, Inc. · 1986
1 generation backK023796 MS Paed-Baby BodyErich Jaeger GmbH · 2003
This deviceK081823 Masterscreen Paed - Baby BodyViasys Healthcare GmbH · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K853390	Infant Body Test	Erich Jaeger, Inc.	1986	—
−1	K023796	MS Paed-Baby Body	Erich Jaeger GmbH	2003	—
0 (this device)	K081823	Masterscreen Paed - Baby Body	Viasys Healthcare GmbH	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0

FIG. 1 — Lineage of K081823, 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? (3)

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
*	K023796	MS Paed-Baby Body Summary page 2 …easurement for babies and lung function measurements for children) 5.9 Legally predicate marketed devices MasterScreen Paed - Baby Body K023796 / Code CCM MasterScreen PFT Body K072061 / Code JEH IPL (Infant Pulmonary Laboratory) or Collins Inf…	Erich Jaeger GmbH	2003	—
*	K072061	Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body Summary page 2 …children) 5.9 Legally predicate marketed devices MasterScreen Paed - Baby Body K023796 / Code CCM MasterScreen PFT Body K072061 / Code JEH IPL (Infant Pulmonary Laboratory) or Collins Infant Plethysmograph K011344 / Code BZC, BZG, CCM 5.1…	Viasys Healthcare GmbH	2008	—
*	K011344	Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400 Summary page 2 …K023796 / Code CCM MasterScreen PFT Body K072061 / Code JEH IPL (Infant Pulmonary Laboratory) or Collins Infant Plethysmograph K011344 / Code BZC, BZG, CCM 5.10 Predicate Device Company VIASYS HEALTHCARE GmbH (since July 01,2007 owned by Card…	Collins Medical, Inc.	2002	—

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.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 17.1 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All CCM devices

CCM Plethysmograph, Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.

The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V I 50-60Hz wall outlet.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081823 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081823: Masterscreen Paed - Baby Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081823

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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