510(k) · Cleared

Cleared

Hydrobrush (TM) Keratome

K971078510(k) TraditionalCleared Jan 23, 1998305-day reviewClass I21 CFR 886.4070

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

Medjet, Inc. · HQS Burr, Corneal, Ac-Powered

Cleared on Jan 23, 1998 after a 305-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Jan 23, 1998
Review: 305 days
Class: Class I
Product code: HQS
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK971078 Hydrobrush (TM) KeratomeMedjet, Inc. · 1998
Descendant · cites it directly · 0 of its ownK991124 Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all

K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971078	Hydrobrush (TM) Keratome	Medjet, Inc.	1998	—
+1	K991124	Visijet Hydrokeratome, Model 50	Visijet, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K971078, 1998–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in HQS? 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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
K991124	Visijet Hydrokeratome, Model 50	Visijet, Inc.	2000	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?

Of its descendants, K991124 (Visijet, Inc., 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HQS devices

HQS Burr, Corneal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQS

FDA has decided no HQS device since 2007.

Median 510(k) review, days · HQS

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

Recalls per year · HQS

No recall names HQS since 2007.

Adverse event reports per year · HQS

1in 2011

2007high 1 (2011) · low 0 (2007)2025

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

View these four charts as a table

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

What is it indicated for?

Any condition which requires removal of the epithelium from the cornea.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971078 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971078: Hydrobrush (TM) Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971078

Report an extraction error

Are you the manufacturer?

Record history

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