510(k) · Cleared

Cleared

Masterscreen Ios

K101873510(k) TraditionalCleared Feb 10, 2011219-day reviewClass II21 CFR 868.1840

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

Carefusion Germany 234 GmbH · BZG Spirometer, Diagnostic

Cleared on Feb 10, 2011 as substantially equivalent to K954140 (Erich Jaeger GmbH & Co. KG, 1995) after a 219-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.

Decided: Feb 10, 2011
Review: 219 days
Class: Class II
Product code: BZG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954140 (1995). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
This deviceK101873 Masterscreen IosCarefusion Germany 234 GmbH · 2011
Descendant · cites it directly · 2 of its ownK152585 Resmon PRO FULLMedical Graphics Corp. · 2016
Descendant · 2 generations on · 1 of its ownK170185 tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2017
Descendant · 3 generations on · 0 of its ownK221024 tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2023

Most influential descendants

Showing 3 of 3 · See all

K152585Resmon PRO FULLMedical Graphics Corp. · 2016 · cites it directly2descendants
K170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2017 · 2 generations on1descendant
K221024tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954140	Masterscreen Ios	Erich Jaeger GmbH & Co. KG	1995	—
0 (this device)	K101873	Masterscreen Ios	Carefusion Germany 234 GmbH	2011	—
+1	K152585	Resmon PRO FULL	Medical Graphics Corp.	2016	—
+2	K170185	tremoFlo C-100 Airwave Oscillometry System	Thorasys Thoracic Medical Systems, Inc.	2017	—
+3	K221024	tremoflo C2 Airwave Oscillometry System	Thorasys Thoracic Medical Systems, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2023	1	0

FIG. 1 — Lineage of K101873, 1995–2023Source: 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 BZG? 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 BZG device

#1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K954140	Masterscreen Ios Summary page 2 …garding "The New 510(k) Paradigm" -- change from 16 bit software to 32 bit software- 5.9 Legally predicate marketed device Masterreen lOS K954140/AOO1 Code BZG 5.10 Predicate Device Company CareFusion Germany 234 GmbH 5.11 Device Description MasterScree…	Erich Jaeger GmbH & Co. KG	1995	—

Also cleared against K954140: 1 other device →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K152585	Resmon PRO FULL	Medical Graphics Corp.	2016	2

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, K152585 (Medical Graphics Corp., 2016) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K954140.

How does its category compare?

All BZG devices

BZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · BZG

2in 2024

2007high 8 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZG

362in 2023

2007high 362 (2023) · low 59 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZG

1in 2024

2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BZG

1in 2025

2007high 3 (2022) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	121	0	1
2008	3	209	0	0
2009	8	141	0	0
2010	4	181	0	0
2011	6	278	0	1
2012	3	59	0	2
2013	3	266	0	1
2014	5	154	0	1
2015	5	273	0	1
2016	4	235	0	1
2017	2	—	0	1
2018	1	—	0	1
2019	3	146	0	1
2020	5	126	0	2
2021	1	—	0	1
2022	2	—	0	3
2023	5	362	0	2
2024	2	—	1	3
2025	0	—	0	1
2026	1	—	0	—

What is it indicated for?

The MasterScreen lOS is intended to be used for measurement and data collection of lung function parameters in humans. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements and the IOS (multifirequent oscillometry determination) measurement. Tests can be easily and quickly conducted on the basis of Impulse Oscillomtry. The device is useful in the field of early diagnosis in…

Read the full statement (127 words)

The MasterScreen lOS is intended to be used for measurement and data collection of

lung function parameters in humans. The system performs cooperation-dependent

pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements

and the IOS (multifirequent oscillometry determination) measurement. Tests can

be easily and quickly conducted on the basis of Impulse Oscillomtry. The device is

useful in the field of early diagnosis in every-day-routine, for clinical trend observations

as well as for epidemniologic studies. As only a minimum of patient cooperation is

required, Impulse Oscillometry is also suitable for pediatric and geriatric studies.

Measurements will be performed under the direction of a physician in the clinic, doctor's

office or hospital.

The MasterScreen lOS is powered from 100-240 V /50-60 Hz wall outlets. No energy is

transferred to the patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101873: Masterscreen Ios.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101873

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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