510(k) Report

FDA applicant

Peregrine Surgical, Ltd.

Doylestown, PA20 decisions1994–20242 recalls

FDA records 20 decisions for Peregrine Surgical, Ltd. (Doylestown, PA) from 1994 to 2024: 20 510(k) clearances. Most are in product codes MPA (Endoilluminator) and HQE (Instrument, Vitreous Aspiration And Cutting…). Its devices cite 11 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Peregrine Surgical, LLC”.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Peregrine Surgical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 32015: 12024: 1
2007high 3 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Peregrine Surgical, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Peregrine Surgical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MPAEndoilluminator6decisions
  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered3decisions
  • HQBPhotocoagulator And Accessories3decisions
  • HJMTransilluminator, Ac-Powered2decisions
  • HQFLaser, Ophthalmic2decisions
  • FRNPump, Infusion1decision

Also: KYG (1), GEX (1), MRH (1).

Whose devices does it build on?

Its devices cite 11 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K024061Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 20034cite it
  • K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 20152cite it
  • K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 20132cite it
  • K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 20032cite it
  • K980797Peregrine Fiber Optic Multi-Function ManipulatorPeregrine Surgical, Ltd. · 19982cite it
  • K990518Peregrine Wet Set, Model PD400.00Peregrine Surgical, Ltd. · 19991cites it

What has FDA decided for it lately?

  • K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga…Peregrine Surgical, LLC · 2024
  • 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
  • K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 20031 recall
  • K024061Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003

All 19 as Peregrine Surgical, Ltd. →The one decision as Peregrine Surgical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K031023Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system…Apr 14, 2021Class II
  • K940393CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.Nov 10, 2003