510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911261Substantially Equivalent

Era 2000A

Neotronics, Inc., Gainesville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911261 is the FDA 510(k) clearance record for ERA 2000A, a class II device, cleared for Neotronics, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 2 510(k) clearances for Neotronics, Inc., from to . As of , FDA records show no recalls naming K911261.

Clearance record

Decision date
Received
(70 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Neotronics, Inc. P.O. Box 370, 2144 Hilton Dr., Gainesville GA
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