510(k) · Cleared
ClearedMB 103 Millennium Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Biomedical, Inc. · HNO Keratome, Ac-Powered
Cleared on Feb 15, 2002 as substantially equivalent to K980924 (Plancon Instruments, 1998) and 1 other predicate after a 248-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 15, 2002
- Review
- 248 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935342 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 2 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 1 generation backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- This deviceK011833 MB 103 Millennium BladesMillennium Biomedical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −2 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −1 | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| 0 (this device) | K011833 | MB 103 Millennium Blades | Millennium Biomedical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K980924 | Plancon Microlamellar Keratome EvolutionSummary page 2…d/or Blades the predicate device or legally marketed device or devices to which substantial equivalence is being claimed: i)evice 510(k) No. Date Cleared Moria CB Blade K980924 04-15-1998 ies Precision Edge K002849 10-18-2000 Microkeratome . Blade 206 May 22, 2001 Millennium Biomedical… | 1998 |
| * | K002849 | Precisionedge-Acc, Precisionedge-Acs, Precisionedge-LSK, and Precisionedge-CB…Summary page 2…gally marketed device or devices to which substantial equivalence is being claimed: i)evice 510(k) No. Date Cleared Moria CB Blade K980924 04-15-1998 ies Precision Edge K002849 10-18-2000 Microkeratome . Blade 206 May 22, 2001 Millennium Biomedical Inc. Premarket Notification MB 103 Mil… | 2000 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K980924.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
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 MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.
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/K011833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011833: MB 103 Millennium Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011833
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026