510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Olympic Pasteurmatic, Models 3000 and 3500

K081094510(k) SpecialCleared Jun 20, 200864-day reviewClass II21 CFR 880.6992Recalls 1

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

Olympic Medical Corp. · MEC Disinfector, Medical Devices

Cleared on Jun 20, 2008 as substantially equivalent to K953645 (Olympic Medical Corp., 1995) after a 64-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.

Decided
Jun 20, 2008
Review
64 days
Class
Class II
Product code
MEC
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K953645 (1995). No later device cites it as a predicate yet.

K953645 · Olympic Pasteurmatic System · Olympic Medical Corp. · 19951995200020052010
K953645 · Olympic Pasteurmatic System · Olympic Medical Corp. · 19950
  1. Root · 1 generation backK953645 Olympic Pasteurmatic SystemOlympic Medical Corp. · 1995
  2. This deviceK081094 Olympic Pasteurmatic, Models 3000 and 3500Olympic Medical Corp. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953645Olympic Pasteurmatic SystemOlympic Medical Corp.1995—
0 (this device)K081094Olympic Pasteurmatic, Models 3000 and 3500Olympic Medical Corp.2008—
FIG. 1 — Lineage of K081094, 1995–2008Source: 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), 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 MEC? 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K953645Olympic Pasteurmatic System
Summary page 1
…roduct Code MEC) Regulatory Class: II ERN: 3018859 1.1.4 Predicate Device Olympic Pasteurmatic System (K953645). 1.1.5 Device Description The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for…
Olympic Medical Corp.1995—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 22, 2017Class IIZ-2701-2017Device DesignOlympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All MEC devices

MEC Disinfector, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MEC

1in 2008

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

2026 to Oct 25, outlined.

Median 510(k) review, days · MEC

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

Recalls per year · MEC

3in 2025

2011: 12013: 12014: 12018: 22020: 12025: 3
2007high 3 (2025) · low 0 (2007)2026

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

Adverse event reports per year · MEC

77in 2025

2007: 12008: 42009: 112010: 182011: 182012: 592013: 1512014: 922015: 822016: 802017: 972018: 732019: 782020: 802021: 932022: 852023: 792024: 782025: 77
2007high 151 (2013) · low 1 (2007)2025

MAUDE reports naming product code MEC, 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—01
20081—04
20090—011
20100—018
20110—118
20120—059
20130—1151
20140—192
20150—082
20160—080
20170—097
20180—273
20190—078
20200—180
20210—093
20220—085
20230—079
20240—078
20250—377
20260—0—

What is it indicated for?

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disirfection of respiratory therapy and anesthesia equipment in a hot water bath at 160 ° 170 ° F for 30 minutes.

Indications for use as stated in the FDA summary.

More from Olympic Medical Corp.

37 FDA decisions under this applicant name. See the company

  • K031149Olympic CFM 6000Olympic Medical Corp. · 2003
  • K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002
  • K001056Olympic Warm-UPOlympic Medical Corp. · 2000
  • K983229Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
  • K971601Olympic Bili-BassinetOlympic Medical Corp. · 1997

Recent decisions in MEC

The MEC category page

  • K911120Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Hamo USA, Inc. · 1994

https://510kreport.com/device/K081094 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081094: Olympic Pasteurmatic, Models 3000 and 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081094

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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