510(k) · Cleared

Recalled · 2007

Ria Kit for Trypsin

K791202510(k) TraditionalCleared Nov 5, 1979130-day reviewClass I21 CFR 862.1725Recalls 1

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

Cis Radiopharmaceuticals, Inc. · JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

Cleared on Nov 5, 1979 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided: Nov 5, 1979
Review: 130 days
Class: Class I
Product code: JNO
Recalls: 1
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK791202 Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 1979
Descendant · cites it directly · 0 of its ownK993697 Delfia Neonatal Irt KitWallac OY · 2000

Most influential descendants

Showing 1 of 1 · See all

K993697Delfia Neonatal Irt KitWallac OY · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K791202	Ria Kit for Trypsin	Cis Radiopharmaceuticals, Inc.	1979	—
+1	K993697	Delfia Neonatal Irt Kit	Wallac OY	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K791202, 1979–2000Source: FDA 510(k) summaries, read by 510(k) Report · 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.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K993697	Delfia Neonatal Irt Kit	Wallac OY	2000	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2007	Not classified	Z-0748-2007	Other	Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K993697 (Wallac OY, 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JNO devices

JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JNO

1in 2011

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JNO

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

Recalls per year · JNO

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · JNO

No MAUDE report names JNO since 2007.

View these four charts as a table

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

https://510kreport.com/device/K791202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791202: Ria Kit for Trypsin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791202

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026