510(k) · Cleared

Cleared

Ricrokeratome Blade

K992978510(k) TraditionalCleared Nov 16, 199974-day reviewClass I21 CFR 886.4370

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

Surgistar, Inc. · HNO Keratome, Ac-Powered

Cleared on Nov 16, 1999 as substantially equivalent to K941550 (Chiron Vision Corp., 1994) after a 74-day review. Its family tree reaches back 1 generation to 1994.

Decided: Nov 16, 1999
Review: 74 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941550 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK941550 Automatic Corneal Shaper Surgical InstrumentChiron Vision Corp. · 1994
This deviceK992978 Ricrokeratome BladeSurgistar, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941550	Automatic Corneal Shaper Surgical Instrument	Chiron Vision Corp.	1994	—
0 (this device)	K992978	Ricrokeratome Blade	Surgistar, Inc.	1999	—

FIG. 1 — Lineage of K992978, 1994–1999Source: 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 HNO? 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
*	K941550	Automatic Corneal Shaper Surgical Instrument Summary page 1 …ratome Blade Legally marketed device to which we are claiming equivalence: Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument (BLADE ONLY) 510(k) Number — K941550 Description of the Device: Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade Intended use of the devi…	Chiron Vision Corp.	1994	—

Also cleared against K941550: 4 other devices →

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.

What does this lineage say?

Its one ancestor has no recall.
4 other devices also cite its predicate K941550.

How does its category compare?

All HNO devices

HNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNO

1in 2018

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HNO

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

Recalls per year · HNO

4in 2011

2007high 4 (2011) · low 0 (2009)2026

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

Adverse event reports per year · HNO

7in 2024

2007high 2,265 (2018) · low 0 (2025)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	32
2008	1	—	2	31
2009	1	—	0	85
2010	0	—	0	84
2011	0	—	4	90
2012	0	—	0	100
2013	0	—	0	353
2014	0	—	0	452
2015	0	—	0	966
2016	0	—	0	1,397
2017	1	—	0	2,112
2018	1	—	0	2,265
2019	0	—	0	816
2020	0	—	0	405
2021	0	—	0	72
2022	0	—	0	7
2023	0	—	0	10
2024	0	—	0	7
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Surgistar Microkeratome is indicated for use as a replacement blade in the

Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS).

The surgical indication for use is in patients undergoing surgery requiring initial

lamellar resection of the cornea.

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/K992978 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992978: Ricrokeratome Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992978

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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