510(k) · Cleared

Cleared

Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020)

K980510510(k) TraditionalCleared May 1, 199880-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

Micro Specialties, Inc. · HNO Keratome, Ac-Powered

Cleared on May 1, 1998 as substantially equivalent to K972727 (Howard Instruments, Inc., 1997) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: May 1, 1998
Review: 80 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K962661 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962661 ML Microkeratome BladeMed-Logics, Inc. · 1996
This deviceK980510 Keratome Blade (135 Micron, Model 300135), (160 Micron, Model…Micro Specialties, Inc. · 1998
Descendant · cites it directly · 0 of its ownK993122 MSP M/K BladeMedical Sterile Products, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all

K993122MSP M/K BladeMedical Sterile Products, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962661	ML Microkeratome Blade	Med-Logics, Inc.	1996	—
0 (this device)	K980510	Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200…	Micro Specialties, Inc.	1998	—
+1	K993122	MSP M/K Blade	Medical Sterile Products, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K980510, 1996–2000Source: 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? (2)

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
*	K972727	Cbalk-1000 Blade Summary page 2 …de is similar in design construction, and function to the devices as marketed by: e Howard Instruments, Inc. Tuscaloosa, AL 35405 Cbalk-1000 LASIK Blade Reference 510k: K972727 e Med-Logics, Inc. Temple City, CA 91780 ML Microkeratome Blade Reference 510k: K962661 Although these blades are supplied with…	Howard Instruments, Inc.	1997	—
*	K962661	ML Microkeratome Blade Summary page 2 …rd Instruments, Inc. Tuscaloosa, AL 35405 Cbalk-1000 LASIK Blade Reference 510k: K972727 e Med-Logics, Inc. Temple City, CA 91780 ML Microkeratome Blade Reference 510k: K962661 Although these blades are supplied without holders their function is the same when fully assembled to the keratome. Descriptive…	Med-Logics, Inc.	1996	—

Also cleared against K972727: 2 other devices →

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
K993122	MSP M/K Blade	Medical Sterile Products, 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?

None of the 2 ancestors has a recall.
Of its descendants, K993122 (Medical Sterile Products, Inc., 2000) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K972727.

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 Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other manufacture’s keratome. These blades are for use in the Insight Technologies Instruments, Model K-SERIES Keratome.

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/K980510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980510: Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980510

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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