510(k) · Cleared

Recalled · 2004

Synchron CX Systems Lipase (Lipa) Reagent

K970905510(k) TraditionalCleared Jun 4, 199784-day reviewClass I21 CFR 862.1465Recalls 1

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

Beckman Instruments, Inc. · CHI Lipase-Esterase, Enzymatic, Photometric, Lipase

Cleared on Jun 4, 1997 as substantially equivalent to K952180 (Beckman Instruments, Inc., 1995) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1988. It has been recalled once.

Decided: Jun 4, 1997
Review: 84 days
Class: Class I
Product code: CHI
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K883181 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
1 generation backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
This deviceK970905 Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883181	Synchron CX4/CX5 Clinical Chemistry Analyzer Reage	Beckman Instruments, Inc.	1988	2
−1	K965240	Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent…	Beckman Instruments, Inc.	1997	12
0 (this device)	K970905	Synchron CX Systems Lipase (Lipa) Reagent	Beckman Instruments, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0

FIG. 1 — Lineage of K970905, 1988–1997Source: 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 CHI? 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? (2)

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
*	K952180	CX Lipase Reagent & Calibrator for Synchron CX Systems Summary page 1 …ems Lipase (LIPA) Reagent Lipase test system (21 CFR 862.1465) 4. Predicate Device(s): htmeaa U Predicate Docket Nimmbei SYNCHRON CX Genzyme Lipase Toye Jozo Co., Ltd K952180 Systems Lipase Reagent (Japan) (LIPA) Reagent SYNCHRON LX SYNCHRON CX Beckman K965240 Clinical System Clinical System Instruments…	Beckman Instruments, Inc.	1995	—
*	K965240	Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX… Summary page 1 …): htmeaa U Predicate Docket Nimmbei SYNCHRON CX Genzyme Lipase Toye Jozo Co., Ltd K952180 Systems Lipase Reagent (Japan) (LIPA) Reagent SYNCHRON LX SYNCHRON CX Beckman K965240 Clinical System Clinical System Instruments, Inc. 5. Description: This assay is designed for use with clinical chemistry analyz…	Beckman Instruments, Inc.	1997	12

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 25, 2004	Not classified	Z-0262-5	Other	Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.5 years on median.
3 of the 5 ancestors have a recall of any class.

How does its category compare?

All CHI devices

CHI Lipase-Esterase, Enzymatic, Photometric, Lipase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHI

FDA has decided no CHI device since 2007.

Median 510(k) review, days · CHI

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

Recalls per year · CHI

1in 2023

2007high 4 (2008) · low 0 (2009)2026

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

Adverse event reports per year · CHI

11in 2025

2007high 32 (2020) · low 0 (2007)2025

MAUDE reports naming product code CHI, 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	—	1	0
2008	—	4	1
2009	—	0	0
2010	—	1	2
2011	—	0	4
2012	—	0	1
2013	—	1	0
2014	—	1	1
2015	—	0	5
2016	—	0	3
2017	—	0	4
2018	—	3	6
2019	—	0	2
2020	—	0	32
2021	—	0	2
2022	—	0	4
2023	—	1	4
2024	—	0	6
2025	—	0	11
2026	—	0	—

What is it indicated for?

The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the guantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

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/K970905 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970905: Synchron CX Systems Lipase (Lipa) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970905

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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