510(k) Report

510(k) · Cleared

Cleared

Ophthalmic Cryo Unit

K940373510(k) TraditionalCleared Jul 18, 1994173-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. · HPS Unit, Cryophthalmic

Cleared on Jul 18, 1994 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jul 18, 1994
Review
173 days
Class
Class II
Product code
HPS
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2001: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK940373 Ophthalmic Cryo UnitDutch Ophthalmic USA, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK012821 D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK202038 CryoTreQVitreQ BV · 2020 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK160591 D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001 · cites it directly1descendant
  • K202038CryoTreQVitreQ BV · 2020 · cites it directly0descendants
  • K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940373Ophthalmic Cryo UnitDutch Ophthalmic USA, Inc.1994—
+1K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc.2001—
+1K202038CryoTreQVitreQ BV20201
+2K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201710
202010
FIG. 1 — Lineage of K940373, 1994–2020Source: 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 HPS? 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 HPS device

  1. #1 K202038 CryoTreQscore -0.8 · 3 generations · no Class I recall
Get a 510(k) Report

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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc.20011
K202038CryoTreQVitreQ BV20200

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, K012821 (Dutch Ophthalmic USA, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HPS devices

HPS Unit, Cryophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPS

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HPS

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

Recalls per year · HPS

3in 2010

2010: 3
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HPS

5in 2011

2010: 12011: 5
2007high 5 (2011) · low 0 (2007)2025

MAUDE reports naming product code HPS, 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—00
20080—00
20090—00
20100—31
20110—05
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dutch Ophthalmic USA, Inc.

10 FDA decisions under this applicant name. See the company

  • K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001
  • K010082D.O.R.C. Harmony Total TTC Vitrectomy SystemDutch Ophthalmic USA, Inc. · 2001
  • K983797D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc. · 1999
  • K980636Fiber Optic Endoillumination ProbeDutch Ophthalmic USA, Inc. · 1998
  • K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997

Recent decisions in HPS

The HPS category page

  • K202038CryoTreQVitreQ BV · 20201 recall
  • K923629Ophthalmic Trichiasis ProbeMira, Inc. · 1992
  • K903303Spembly Medical 242 Cryounit/Series 242 CryoprobesSpembly Medical, Ltd. · 1990
  • K874555Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
  • K873388Keeler Ctu Cryo SystemKeeler Instruments, Inc. · 1987

https://510kreport.com/device/K940373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940373: Ophthalmic Cryo Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940373

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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