Amylase (Ethylidene PNGPG7) Kit

K953211510(k) TraditionalCleared Jun 21, 1996347-day reviewClass II21 CFR 862.1070Recalls 1

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

Randox Laboratories, Ltd. · CIJ Saccharogenic, Amylase

Cleared on Jun 21, 1996 after a 347-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided: Jun 21, 1996
Review: 347 days
Class: Class II
Product code: CIJ
Recalls: 1
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K953211Source: FDA 510(k) database · How lineage is built

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

Planning a device in CIJ? 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
Jul 10, 2020	Class II	Z-2923-2020	Under Investigation by firm	Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CIJ devices

CIJ Saccharogenic, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIJ

FDA has decided no CIJ device since 2007.

Median 510(k) review, days · CIJ

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

Recalls per year · CIJ

No recall names CIJ since 2007.

Adverse event reports per year · CIJ

1in 2015

2007high 1 (2015) · low 0 (2007)2025

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

View these four charts as a table

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

https://510kreport.com/device/K953211 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953211: Amylase (Ethylidene PNGPG7) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953211

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026