510(k) · Cleared

Cleared

D.O.R.C. Cryostar Cryosurgical System

K012821510(k) TraditionalCleared Oct 22, 200160-day reviewClass II21 CFR 886.4170

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

Dutch Ophthalmic USA, Inc. · HRN Unit, Cryophthalmic, Ac-Powered

Cleared on Oct 22, 2001 as substantially equivalent to K940373 (Dutch Ophthalmic USA, Inc., 1994) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Oct 22, 2001
Review: 60 days
Class: Class II
Product code: HRN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K940373 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK940373 Ophthalmic Cryo UnitDutch Ophthalmic USA, Inc. · 1994
This deviceK012821 D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001
Descendant · cites it directly · 0 of its ownK160591 D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017

Most influential descendants

Showing 1 of 1 · See all

K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940373	Ophthalmic Cryo Unit	Dutch Ophthalmic USA, Inc.	1994	—
0 (this device)	K012821	D.O.R.C. Cryostar Cryosurgical System	Dutch Ophthalmic USA, Inc.	2001	—
+1	K160591	D.O.R.C. Disposable Cryo Probe	Dutch Ophthalmic Research Center International BV	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K012821, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in HRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRN device

#1 K200911 MIRA Adapterscore 0.3 · 4 generations · no Class I recall

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K940373	Ophthalmic Cryo Unit Summary page 1 …fication Name: Unit, Cryophthalmic, AC-Powered (HRN & 21CFR 886.4170) PREDICATE DEVICES Manufacturer Product Name 510(k) Number Spembly Medical Ltd D.O.R.C. Cryo 1500 K940373 Spembly Medical Ltd Keeler Cryo Master K992954 DEVICE DESCRIPTION The D.O.R.C. CryoStar Cryosurgical System consists of a cryo…	Dutch Ophthalmic USA, Inc.	1994	—
*	K992954	Keeler Cryo Master & Probes Summary page 1 …HRN & 21CFR 886.4170) PREDICATE DEVICES Manufacturer Product Name 510(k) Number Spembly Medical Ltd D.O.R.C. Cryo 1500 K940373 Spembly Medical Ltd Keeler Cryo Master K992954 DEVICE DESCRIPTION The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe,…	Keeler Instruments, Inc.	1999	—

Also cleared against K940373: 1 other device →

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
K160591	D.O.R.C. Disposable Cryo Probe	Dutch Ophthalmic Research Center International BV	2017	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K160591 (Dutch Ophthalmic Research Center International BV, 2017) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K940373.

How does its category compare?

All HRN devices

HRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRN

1in 2020

2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRN

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

Recalls per year · HRN

No recall names HRN since 2007.

Adverse event reports per year · HRN

1in 2019

2007high 2 (2015) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	2
2016	0	—	0
2017	2	—	0
2018	1	—	0
2019	0	—	1
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The D.O.R.C. CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis and retinopathy of prematurity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012821: D.O.R.C. Cryostar Cryosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012821

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026