510(k) Report

510(k) · Cleared

Cleared

MDT/Harvey MC-8 and MC-10

K924955510(k) TraditionalCleared Oct 15, 1993380-day reviewClass II21 CFR 880.6880

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

Mdt Corp., Inc. · FLE Sterilizer, Steam

Cleared on Oct 15, 1993 after a 380-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Oct 15, 1993
Review
380 days
Class
Class II
Product code
FLE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared1990200020102020
  1. This deviceK924955 MDT/Harvey MC-8 and MC-10Mdt Corp., Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK014174 Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K014174Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924955MDT/Harvey MC-8 and MC-10Mdt Corp., Inc.1993—
+1K014174Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K924955, 1993–2002Source: 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 FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FLE device

  1. #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (1)

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

NumberDeviceApplicantDecidedDescendants
K014174Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp.20020

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, K014174 (Barnstead/Thermolyne Corp., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLE

4in 2025

2007: 52008: 12009: 82010: 22011: 52012: 52013: 52014: 22015: 32016: 12017: 32018: 82019: 52020: 22021: 52022: 102023: 72024: 22025: 42026 (partial year): 3
2007high 10 (2022) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLE

184in 2025

2007: 67 days median2009: 109 days median2011: 141 days median2012: 111 days median2013: 241 days median2015: 302 days median2017: 233 days median2018: 146 days median2019: 192 days median2021: 147 days median2022: 133 days median2023: 88 days median2025: 184 days median2026 (partial year): 85 days median
2007high 302 (2015) · low 67 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLE

1in 2021

2007: 12008: 12011: 12012: 12013: 22015: 12018: 12019: 22021: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2009)2026

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

Adverse event reports per year · FLE

71in 2025

2007: 192008: 212009: 192010: 202011: 632012: 692013: 1122014: 1132015: 682016: 762017: 632018: 902019: 912020: 872021: 812022: 702023: 662024: 642025: 71
2007high 113 (2014) · low 19 (2007)2025

MAUDE reports naming product code FLE, 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
2007567119
20081—121
20098109019
20102—020
20115141163
20125111169
201352412112
20142—0113
20153302168
20161—076
20173233063
20188146190
20195192291
20202—087
20215147181
202210133070
2023788066
20242—064
20254184071
20263851—

More from Mdt Corp., Inc.

22 FDA decisions under this applicant name. See the company

  • K960777MDT Unispore and Spor-Test BiologicalindicatorMdt Corp., Inc. · 1996
  • K942485MDT Urology TableMdt Corp., Inc. · 1994
  • K942486Image Full Power Examination/Minor Surgery TableMdt Corp., Inc. · 1994
  • K924380MDT/Harvey Model 7000 & 8000 ChemiclaveMdt Corp., Inc. · 1994
  • K926081Dental LightMdt Corp., Inc. · 1994

Recent decisions in FLE

The FLE category page

  • K261055AMSCO 700 Steam SterilizerSTERIS Corporation · 2026
  • K260254Enbio PROEnbio Group AG · 2026
  • K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company) · 2026
  • K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
  • K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd. · 2025

https://510kreport.com/device/K924955 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924955: MDT/Harvey MC-8 and MC-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924955

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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