510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071221Substantially Equivalent

Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12

Automedx, Inc., Germantown MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071221 is the FDA 510(k) clearance record for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12, a class II device, cleared for Automedx, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 2 510(k) clearances for Automedx, Inc., from to . As of , FDA records show no recalls naming K071221.

Clearance record

Decision date
Received
(127 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Automedx, Inc. 12321 Middlebrook Rd., Germantown MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTL

Trailing 12 months

FDA records hold no clearances under product code BTL in the trailing twelve months.

FDA records show no clearances under product code BTL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260