510(k) Report

510(k) · Cleared

Cleared

Personna Safety Scalpel

K924503510(k) TraditionalCleared Feb 5, 1993154-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Safety Razor Co. · MDM Instrument, Manual, Surgical, General Use

Cleared on Feb 5, 1993 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. 1 later device descends from it.

Decided
Feb 5, 1993
Review
154 days
Class
Class I
Product code
MDM
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared1990200020102020
  1. This deviceK924503 Personna Safety ScalpelAmerican Safety Razor Co. · 1993
  2. Descendant · cites it directly · 0 of its ownK032242 Personna Plus Safety Scalpel SystemOmi Manufacturing Pty., Ltd. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K032242Personna Plus Safety Scalpel SystemOmi Manufacturing Pty., Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924503Personna Safety ScalpelAmerican Safety Razor Co.1993—
+1K032242Personna Plus Safety Scalpel SystemOmi Manufacturing Pty., Ltd.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K924503, 1993–2003Source: 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.

Planning a device in MDM? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032242Personna Plus Safety Scalpel SystemOmi Manufacturing Pty., Ltd.20030

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, K032242 (Omi Manufacturing Pty., Ltd., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MDM devices

MDM Instrument, Manual, Surgical, General Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDM

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDM

Too few MDM 510(k)s in any year since 2007 to give a median.

Recalls per year · MDM

1in 2024

2009: 12010: 172011: 12014: 12017: 22021: 12022: 22024: 12026 (partial year): 1
2007high 17 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MDM

318in 2025

2007: 252008: 502009: 1312010: 492011: 522012: 532013: 742014: 662015: 1612016: 3172017: 1872018: 4002019: 2812020: 2452021: 2272022: 1822023: 2092024: 5072025: 318
2007high 507 (2024) · low 25 (2007)2025

MAUDE reports naming product code MDM, 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—025
20081—050
20090—1131
20100—1749
20110—152
20120—053
20130—074
20140—166
20150—0161
20160—0317
20170—2187
20180—0400
20190—0281
20200—0245
20210—1227
20220—2182
20230—0209
20240—1507
20250—0318
20260—1—

More from American Safety Razor Co.

4 FDA decisions under this applicant name. See the company

  • K873142Personna Disposable ScalpelAmerican Safety Razor Co. · 1987
  • K863557Blade, Surgical Preparation Razor, Straight,SingleAmerican Safety Razor Co. · 1986
  • K771045Blades, ScalpelAmerican Safety Razor Co. · 1977

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https://510kreport.com/device/K924503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924503: Personna Safety Scalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924503

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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