510(k) · Cleared
ClearedPersonna Plus Safety Scalpel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omi Manufacturing Pty., Ltd. · GES Blade, Scalpel
Cleared on Sep 23, 2003 as substantially equivalent to K923170 (Innovative Surgical Technology, Inc., 1993) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 23, 2003
- Review
- 64 days
- Class
- Class I
- Product code
- GES
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924503 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924503 Personna Safety ScalpelAmerican Safety Razor Co. · 1993
- This deviceK032242 Personna Plus Safety Scalpel SystemOmi Manufacturing Pty., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924503 | Personna Safety Scalpel | American Safety Razor Co. | 1993 | — |
| 0 (this device) | K032242 | Personna Plus Safety Scalpel System | Omi Manufacturing Pty., Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 GES? 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 |
|---|---|---|---|
| * | K923170 | Los Alamos Retractable KnifeSummary page 1…ndle: GDZ CommodUsual Name: Scalpel blade, scalpel handle This device is Class I but with sharps injury protection feature. 2. Equivalent legally marketed device: K923 170 Los Alamos Retractable Knife and Personna Safety Scalpel” K924503 3. Indications for Use (intended use) The PersonnaPlus Safe… | 1993 |
| * | K924503 | Personna Safety ScalpelSummary page 1…evice is Class I but with sharps injury protection feature. 2. Equivalent legally marketed device: K923 170 Los Alamos Retractable Knife and Personna Safety Scalpel” K924503 3. Indications for Use (intended use) The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as… | 1993 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GES devicesGES Blade, Scalpel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GES
FDA has decided no GES device since 2007.
Median 510(k) review, days · GES
Too few GES 510(k)s in any year since 2007 to give a median.
Recalls per year · GES
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GES
38in 2025
MAUDE reports naming product code GES, 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 | — | 3 | 28 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 1 | 18 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 4 | 35 |
| 2013 | 0 | — | 0 | 125 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 73 |
| 2018 | 0 | — | 0 | 80 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 35 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PersonnaPIus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading. passing, and disposal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032242 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032242: Personna Plus Safety Scalpel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032242
Report an extraction error
Are you the manufacturer?
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