510(k) · Cleared
ClearedMeridian Cranial Perforator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adeor Medical Technologies GmbH · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Jul 17, 2012 as substantially equivalent to K933894 (Codman & Shurtleff, Inc., 1993) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Jul 17, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K791101 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| −1 | K933894 | Disposable Perforator | Codman & Shurtleff, Inc. | 1993 | — |
| 0 (this device) | K121253 | Meridian Cranial Perforator | Adeor Medical Technologies GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2007 | 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 HBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBF device
- #1 K231403 evoDrill Cranial Perforatorscore 13.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K933894 | Disposable PerforatorSummary page 2…least 3 mm. The Meridian TM pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm. Predicate Devices: K933894, K071931 2 Disposable Perforators 2 Codman & Shurtleff, Inc. K833266 ~… | 1993 |
| * | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223Summary page 2…mm. The Meridian TM pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm. Predicate Devices: K933894, K071931 2 Disposable Perforators 2 Codman & Shurtleff, Inc. K833266 ~~Automati… | 2007 |
| * | K833266 | Acra-CutSummary page 2…bone thickness of at least 1.5 mm. Predicate Devices: K933894, K071931 2 Disposable Perforators 2 Codman & Shurtleff, Inc. K833266 ~~Automatic Cranial Drill Ar uIc K833266 ~(Perforator)… | 1983 |
| * | — | Acra-Cut DGR-1 and DGR-11 Named without a submission number | |
| * | — | Codman 26-1221 Named without a submission number |
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 33 years and passes through 2 companies; a new generation was cleared every 18.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K933894.
How does its category compare?
All HBF devicesHBF Drills, Burrs, Trephines & Accessories (Compound, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBF
103in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBF
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · HBF
113in 2025
MAUDE reports naming product code HBF, 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 | 1 | — | 0 | 25 |
| 2008 | 3 | 103 | 0 | 41 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 73 |
| 2011 | 0 | — | 1 | 39 |
| 2012 | 1 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 103 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 1 | — | 0 | 59 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 106 |
| 2018 | 0 | — | 0 | 136 |
| 2019 | 1 | — | 0 | 208 |
| 2020 | 0 | — | 1 | 324 |
| 2021 | 0 | — | 0 | 309 |
| 2022 | 1 | — | 0 | 148 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 1 | — | 0 | 179 |
| 2025 | 0 | — | 2 (2) | 113 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MeridianTM Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian"m pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm. Pediatric: for bone thickness of at least 1.5 mm: For…
Read the full statement (94 words)
The MeridianTM Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm.
The Meridian"m pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm.
The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.
Pediatric: for bone thickness of at least 1.5 mm: For bone thickness of at least 3.0 mm:
PER 6-9-SP IPER 6-9-S
PER 7-11 -SP PER 7-11 -S
PER 11-14-SP PER 11-14-S
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121253: Meridian Cranial Perforator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121253
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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