510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K884089Substantially Equivalent

Era 2000 Emergency Resuscitator

Neotronics Medical, Ltd., Bishop'S Stortford, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884089 is the FDA 510(k) clearance record for ERA 2000 EMERGENCY RESUSCITATOR, a class II device, cleared for Neotronics Medical , Ltd. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list one 510(k) clearance for Neotronics Medical , Ltd. As of , FDA records show no recalls naming K884089.

Clearance record

Decision date
Received
(83 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Neotronics Medical , Ltd. Parsonage Rd., Bishop'S Stortford, GB
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