510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K935755Substantially Equivalent

The Ultra

Medical Device Systems, Inc., Auburndale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935755 is the FDA 510(k) clearance record for THE ULTRA, a class II device, cleared for Medical Device Systems, Inc. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list one 510(k) clearance for Medical Device Systems, Inc. As of , FDA records show no recalls naming K935755.

Clearance record

Decision date
Received
(525 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Medical Device Systems, Inc. 212 E. Park St., Auburndale FL
510(k) summary
Statement
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 clearances under product code KCT in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20260