510(k) · Cleared

Recalled · 2003

Peregrine Wide Angle Light Pipe

K940393510(k) TraditionalCleared Sep 2, 1994219-day reviewClass II21 CFR 886.1945Recalls 1

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

Peregrine Surgical, Ltd. · HJM Transilluminator, Ac-Powered

Cleared on Sep 2, 1994 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided: Sep 2, 1994
Review: 219 days
Class: Class II
Product code: HJM
Recalls: 1
Predicates: 0

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

This deviceK940393 Peregrine Wide Angle Light PipePeregrine Surgical, Ltd. · 1994
Descendant · cites it directly · 0 of its ownK972506 Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K972506Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940393	Peregrine Wide Angle Light Pipe	Peregrine Surgical, Ltd.	1994	—
+1	K972506	Infinitech Bullet Endo Illuminated Pick Manipulator	Infinitech, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K940393, 1994–1997Source: 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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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?

FDA lists a 510(k) statement for it but has not posted the file, 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
K972506	Infinitech Bullet Endo Illuminated Pick Manipulator	Infinitech, Inc.	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2003	Not classified	Z-0264-04	Other	The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K972506 (Infinitech, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HJM devices

HJM Transilluminator, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJM

FDA has decided no HJM device since 2007.

Median 510(k) review, days · HJM

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

Recalls per year · HJM

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HJM

1in 2016

2007high 2 (2015) · low 0 (2008)2025

MAUDE reports naming product code HJM, 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	1
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	1
2014	—	0	0
2015	—	0	2
2016	—	0	1
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K940393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940393: Peregrine Wide Angle Light Pipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940393

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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