510(k) Report

510(k) · Cleared

Cleared

4MM & 5MM File

K841981510(k) TraditionalCleared Jun 19, 198436-day reviewClass I21 CFR 888.4540

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

Stainless Mfg., Inc. · HTP File

Cleared on Jun 19, 1984 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 19, 1984
Review
36 days
Class
Class I
Product code
HTP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K841981Source: 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 HTP? 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 HTP devices

HTP File: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTP

FDA has decided no HTP device since 2007.

Median 510(k) review, days · HTP

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

Recalls per year · HTP

No recall names HTP since 2007.

Adverse event reports per year · HTP

1in 2022

2018: 12019: 12020: 62022: 1
2007high 6 (2020) · low 0 (2007)2025

MAUDE reports naming product code HTP, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—01
20200—06
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Stainless Mfg., Inc.

19 FDA decisions under this applicant name. See the company

  • K841980Side Cutting Serrated BladeStainless Mfg., Inc. · 1984
  • K841982Meniscotome 4MM & 5MMStainless Mfg., Inc. · 1984
  • K841974Retrograde Knife 4MM & 5MMStainless Mfg., Inc. · 1984
  • K8419696.5MM Hex HandleStainless Mfg., Inc. · 1984
  • K841970Camelback Handle-K841969-LabelingStainless Mfg., Inc. · 1984

Recent decisions in HTP

The HTP category page

  • K931733Intermedics Orthopedics ReamersIntermedics Orthopedics · 1994
  • K870842Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspWarsaw Orthopedic, Inc. · 1987
  • K862659Concept Arthroscopy RaspConcept, Inc. · 1986
  • K840492Sun-Lite Blue SlitSuncoast Medical Manufacturers, Inc. · 1984

https://510kreport.com/device/K841981 · printed Nov 3, 2026

Cite this page

510(k) Report. “K841981: 4MM & 5MM File.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K841981

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