510(k) Report

510(k) · Cleared

Cleared

Prizm Keratome Blade, Model MK8512M2

K033236510(k) TraditionalCleared Mar 26, 2004172-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

Surgin Surgical Instrumentation, Inc. · HNO Keratome, Ac-Powered

Cleared on Mar 26, 2004 after a 172-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Mar 26, 2004
Review
172 days
Class
Class I
Product code
HNO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK033236 Prizm Keratome Blade, Model MK8512M2Surgin Surgical Instrumentation, Inc. · 2004
  2. Descendant · cites it directly · 0 of its ownK041110 MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K041110MB 105 Millennium BladesMillennium Biomedical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033236Prizm Keratome Blade, Model MK8512M2Surgin Surgical Instrumentation, Inc.2004—
+1K041110MB 105 Millennium BladesMillennium Biomedical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K033236, 2004–2004Source: 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), 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 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?

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.

NumberDeviceApplicantDecidedDescendants
K041110MB 105 Millennium BladesMillennium Biomedical, Inc.20040

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, K041110 (Millennium Biomedical, Inc., 2004) has gone furthest, with 0 descendants 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—

What is it indicated for?

The Prizm Keratome Blade VII is to be used as a replacement blade for the non-disposable Moria M2 keratome for lamellar resection of the cornea

Indications for use as stated in the FDA 510(k) statement.

More from Surgin Surgical Instrumentation, Inc.

23 FDA decisions under this applicant name. See the company

  • K082110Dual Syringe HolderSurgin Surgical Instrumentation, Inc. · 2009
  • K033182Prizm Keratome Blade (B.D. Model), Model MK8530BDSurgin Surgical Instrumentation, Inc. · 2004
  • K011195Prizm Blade (Moria Model) LSK / MK8510LSK; Prizm Blade (Moria Model) CB / MK8511CBSurgin Surgical Instrumentation, Inc. · 2001
  • K994015Accublade (Acs Model), MK8507, Accublade (Hansotome Model), MK8508Surgin Surgical Instrumentation, Inc. · 2000
  • K980849Surgin KitSurgin Surgical Instrumentation, Inc. · 1998

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/K033236 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033236: Prizm Keratome Blade, Model MK8512M2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033236

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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