510(k) · Cleared

Cleared

Abca Gas Isotope Ratio Mass Spectrometer Systems

K992163510(k) SpecialCleared Jul 13, 199918-day reviewClass I21 CFR 862.2860

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

Pdz-Europa, Ltd. · DOP Mass Spectrometer, Clinical Use

Cleared on Jul 13, 1999 as substantially equivalent to K974322 (Europa Scientific, Ltd., 1997) after an 18-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jul 13, 1999
Review: 18 days
Class: Class I
Product code: DOP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974322 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
This deviceK992163 Abca Gas Isotope Ratio Mass Spectrometer SystemsPdz-Europa, Ltd. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974322	Abca-NT Gas Isotope Ratio Mass Spectrometer System	Europa Scientific, Ltd.	1997	—
0 (this device)	K992163	Abca Gas Isotope Ratio Mass Spectrometer Systems	Pdz-Europa, Ltd.	1999	—

FIG. 1 — Lineage of K992163, 1997–1999Source: 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 DOP? 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
*	K974322	Abca-NT Gas Isotope Ratio Mass Spectrometer System Summary page 1 …ress, Contact Person and Date of Preparation PDZ Europa Limited Europa House, Electra Way Crewe, Cheshire CW1 6ZA United Kingdom Note that the predicate device 510(k), K974322, was submitted under the name Europa Scientific Limited. Effective November 3, 1998, Europa Scientific Limited (Europa House, Ele…	Europa Scientific, Ltd.	1997	—

Also cleared against K974322: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K974322.

How does its category compare?

All DOP devices

DOP Mass Spectrometer, Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DOP

FDA has decided no DOP device since 2007.

Median 510(k) review, days · DOP

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

Recalls per year · DOP

4in 2023

2007high 4 (2023) · low 0 (2007)2026

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

Adverse event reports per year · DOP

1in 2025

2007high 4 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	2
2011	—	0	4
2012	—	0	3
2013	—	0	3
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	0	3
2018	—	1	1
2019	—	0	0
2020	—	0	0
2021	—	1	0
2022	—	0	1
2023	—	4	4
2024	—	0	2
2025	—	0	1
2026	—	0	—

What is it indicated for?

The ABCA is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS)

System intended for use in the measurement of stable isotopes of carbon, nitrogen,

and oxygen in gas samples. For this purpose, the system is comprised of a gas

sampling module, a gas purification module, and an isotope ratio mass spectrometer

which are synchronously coupled by means of an external personal computer which

also collects and archives data.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992163 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992163: Abca Gas Isotope Ratio Mass Spectrometer Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992163

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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