510(k) Report

510(k) · Cleared

Cleared

ACU220 Cryo Unit

K841294510(k) TraditionalCleared Aug 15, 1984139-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

Keller Instruments, Inc. · HQA Unit, Cryotherapy, Ophthalmic

Cleared on Aug 15, 1984 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 15, 1984
Review
139 days
Class
Class II
Product code
HQA
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K841294Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All HQA devices

HQA Unit, Cryotherapy, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQA

FDA has decided no HQA device since 2007.

Median 510(k) review, days · HQA

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

Recalls per year · HQA

No recall names HQA since 2007.

Adverse event reports per year · HQA

1in 2024

2017: 12018: 22019: 212020: 92021: 152022: 52023: 12024: 1
2007high 21 (2019) · low 0 (2007)2025

MAUDE reports naming product code HQA, 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—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—02
20190—021
20200—09
20210—015
20220—05
20230—01
20240—01
20250—00
20260—0—

More from Keller Instruments, Inc.

5 FDA decisions under this applicant name. See the company

  • K854541Tip Off ForcepsKeller Instruments, Inc. · 1985
  • K841293Panoramic Loupes - VariousKeller Instruments, Inc. · 1984
  • K841292Spectacle Indirect OphthalmoscopeKeller Instruments, Inc. · 1984
  • K823835Spembly 140 Cryosystem Probes & TipsKeller Instruments, Inc. · 1983

Recent decisions in HQA

The HQA category page

  • K854411Keeler-Compact Cryo SystemKeeler Instruments, Inc. · 1985
  • K854422Series 25 Slimline Cryo ProbesKeeler Instruments, Inc. · 1985
  • K823835Spembly 140 Cryosystem Probes & TipsKeller Instruments, Inc. · 1983

https://510kreport.com/device/K841294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K841294: ACU220 Cryo Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841294

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026