510(k) Report

510(k) · Cleared

Cleared

Peregrine Pic Minipulator

K940392510(k) TraditionalCleared Aug 23, 1994209-day reviewClass I21 CFR 886.4360

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

Peregrine Surgical, Ltd. · KYG Device, Irrigation, Ocular Surgery

Cleared on Aug 23, 1994 after a 209-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.

Decided
Aug 23, 1994
Review
209 days
Class
Class I
Product code
KYG
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK940392 Peregrine Pic MinipulatorPeregrine Surgical, Ltd. · 1994
  2. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940392Peregrine Pic MinipulatorPeregrine Surgical, Ltd.1994—
+1K972506Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K940392, 1994–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KYG? 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?

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.

NumberDeviceApplicantDecidedDescendants
K972506Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc.19970

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?

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

How does its category compare?

All KYG devices

KYG Device, Irrigation, Ocular Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYG

FDA has decided no KYG device since 2007.

Median 510(k) review, days · KYG

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

Recalls per year · KYG

1in 2023

2007: 42010: 22023: 1
2007high 4 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KYG

72in 2025

2007: 1032008: 612009: 502010: 1272011: 812012: 3322013: 2422014: 2582015: 792016: 142017: 102018: 102019: 132020: 82021: 192022: 202023: 232024: 812025: 72
2007high 332 (2012) · low 8 (2020)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—4103
20080—061
20090—050
20100—2127
20110—081
20120—0332
20130—0242
20140—0258
20150—079
20160—014
20170—010
20180—010
20190—013
20200—08
20210—019
20220—020
20230—123
20240—081
20250—072
20260—0—

More from Peregrine Surgical, Ltd.

19 FDA decisions under this applicant name. See the company

  • K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
  • K132614Peregrine Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
  • K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
  • K122905Peregrine 23GA Curved Laser ProbePeregrine Surgical, Ltd. · 2013
  • K061024Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60Peregrine Surgical, Ltd. · 2006

Recent decisions in KYG

The KYG category page

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  • K003036Turbo-Flow Infusion Cannula 19 Gage,20 Gage,23 Gage, 25 Gage, Model 101019,101020,101023,101025Retinalabs.Com · 2000
  • K993591Bladeworks Disposable Alk TubingBlade Works, Inc. · 1999
  • K981116Sovereign Cataract Extraction SystemAllergan, Inc. · 19981 recall
  • K980647Eye Irrigator Model #2020Eye-Deal Ocular Safety Products, Inc. · 1998

https://510kreport.com/device/K940392 · printed Nov 3, 2026

Cite this page

510(k) Report. “K940392: Peregrine Pic Minipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K940392

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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