510(k) Report

510(k) · Cleared

Cleared

Surgical Prep Razor

K874370510(k) TraditionalCleared Nov 13, 198718-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

Derma-Safe Co. · LWK Razor, Surgical

Cleared on Nov 13, 1987 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 13, 1987
Review
18 days
Class
Class I
Product code
LWK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K874370Source: FDA 510(k) database · 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 LWK? 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 has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All LWK devices

LWK Razor, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWK

FDA has decided no LWK device since 2007.

Median 510(k) review, days · LWK

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

Recalls per year · LWK

1in 2019

2018: 12019: 1
2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · LWK

14in 2025

2007: 142008: 142010: 42011: 52012: 62013: 92014: 92015: 52016: 102017: 122018: 52019: 312020: 92021: 112022: 82023: 42024: 82025: 14
2007high 31 (2019) · low 0 (2009)2025

MAUDE reports naming product code LWK, 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—014
20080—014
20090—00
20100—04
20110—05
20120—06
20130—09
20140—09
20150—05
20160—010
20170—012
20180—15
20190—131
20200—09
20210—011
20220—08
20230—04
20240—08
20250—014
20260—0—

More from Derma-Safe Co.

2 FDA decisions under this applicant name. See the company

  • K874234Surgical Prep Razor, Straight TypeDerma-Safe Co. · 1987

Recent decisions in LWK

The LWK category page

  • K9461623M (TM) Surgical Slipper, 9660 SeriesWahl Clipper Corp. · 1995
  • K910524Surgical ClipperBaxter Healthcare Corp · 1991
  • K874234Surgical Prep Razor, Straight TypeDerma-Safe Co. · 1987

https://510kreport.com/device/K874370 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874370: Surgical Prep Razor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874370

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026