510(k) · Cleared

Cleared

Moistair Fluid Air Tubing Set

K974561510(k) TraditionalCleared Feb 19, 199876-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

American Medical Devices, Inc. · KYG Device, Irrigation, Ocular Surgery

Cleared on Feb 19, 1998 after a 76-day review. The FDA summary names its predicate without a number.

Decided: Feb 19, 1998
Review: 76 days
Class: Class I
Product code: KYG
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K974561Source: FDA 510(k) database · 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 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? (1)

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
*	—	Grieshaber & Co. Named without a submission number			—

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 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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	4	103
2008	—	0	61
2009	—	0	50
2010	—	2	127
2011	—	0	81
2012	—	0	332
2013	—	0	242
2014	—	0	258
2015	—	0	79
2016	—	0	14
2017	—	0	10
2018	—	0	10
2019	—	0	13
2020	—	0	8
2021	—	0	19
2022	—	0	20
2023	—	1	23
2024	—	0	81
2025	—	0	72
2026	—	0	—

What is it indicated for?

For infusion of fluid and air during vitrectomy.

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/K974561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974561: Moistair Fluid Air Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974561

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026