510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880487Substantially Equivalent

Neotech Meconium Aspirator (Sterile)

Neotech Products, LLC, Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880487 is the FDA 510(k) clearance record for NEOTECH MECONIUM ASPIRATOR (STERILE), a class II device, cleared for Neotech Products, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 6 510(k) clearances for Neotech Products, Inc., from to . As of , FDA records show no recalls naming K880487.

Clearance record

Decision date
Received
(92 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Neotech Products, Inc. 9135 Alabama Ave., Suite F, Chatsworth CA
Third party review
No

Clearances, product code BTR

Trailing 12 months
2 clearances under product code BTR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260