510(k) Report

510(k) · Cleared

Cleared

ML Microkeratome Blade

K962661510(k) TraditionalCleared Dec 9, 1996154-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

Med-Logics, Inc. · HNO Keratome, Ac-Powered

Cleared on Dec 9, 1996 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 9, 1996
Review
154 days
Class
Class I
Product code
HNO
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2000: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962661 ML Microkeratome BladeMed-Logics, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK980508 Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D.…Micro Specialties, Inc. · 1998
  3. Descendant · cites it directly · 1 of its ownK980510 Keratome Blade (135 Micron, Model 300135), (160 Micron, Model…Micro Specialties, Inc. · 1998
  4. Descendant · cites it directly · 0 of its ownK993122 MSP M/K BladeMedical Sterile Products, Inc. · 2000

Most influential descendants

Showing 3 of 3 · See all
  • K980508Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome…Micro Specialties, Inc. · 1998 · cites it directly1descendant
  • K980510Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…Micro Specialties, Inc. · 1998 · cites it directly1descendant
  • K993122MSP M/K BladeMedical Sterile Products, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962661ML Microkeratome BladeMed-Logics, Inc.1996—
+1K980508Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model…Micro Specialties, Inc.1998—
+1K980510Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200…Micro Specialties, Inc.1998—
+1K993122MSP M/K BladeMedical Sterile Products, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200010
FIG. 1 — Lineage of K962661, 1996–2000Source: FDA 510(k) summaries, read by 510(k) Report · 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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  • 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980508Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome…Micro Specialties, Inc.19981
K980510Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…Micro Specialties, Inc.19981
K993122MSP M/K BladeMedical Sterile Products, Inc.20000

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, K980508 (Micro Specialties, Inc., 1998) has gone furthest, with 1 descendant of its own.

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

2008: 12009: 12017: 12018: 1
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

2007: 22008: 22011: 4
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

2007: 322008: 312009: 852010: 842011: 902012: 1002013: 3532014: 4522015: 9662016: 1,3972017: 2,1122018: 2,2652019: 8162020: 4052021: 722022: 72023: 102024: 7
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—232
20081—231
20091—085
20100—084
20110—490
20120—0100
20130—0353
20140—0452
20150—0966
20160—01,397
20171—02,112
20181—02,265
20190—0816
20200—0405
20210—072
20220—07
20230—010
20240—07
20250—00
20260—0—

More from Med-Logics, Inc.

12 FDA decisions under this applicant name. See the company

  • K033293Med-Logics, Model ML7090Med-Logics, Inc. · 20041 recall
  • K022982Med-Logics Microkeratome Blade, Model 7050CLBMed-Logics, Inc. · 2002
  • K022716Med-Logics Microkeratome Blade, Model 7020CLBMed-Logics, Inc. · 2002
  • K010872ML Blade, Model ML7030Med-Logics, Inc. · 2001
  • K010353Med-Logics Disposable Alk TubingMed-Logics, Inc. · 2001

Recent decisions in HNO

The HNO category page

  • K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc. · 2018
  • K172994EPI K ConsoleMoria SA · 2017
  • K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009
  • K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
  • K062465Zyoptix XP Epi Separator SystemBausch & Lomb, Inc. · 20061 recall

https://510kreport.com/device/K962661 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962661: ML Microkeratome Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962661

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