510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191138Substantially Equivalent

AeroForm Tissue Expander, Smooth

Airxpanders, Inc., San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191138 is the FDA 510(k) clearance record for AeroForm Tissue Expander, Smooth, a class II device, cleared for Airxpanders, Inc. on under FDA product code PQN (Carbon Dioxide Gas Controlled Tissue Expander). FDA's definition for product code PQN reads: "A carbon dioxide gas controlled tissue expander is intended for tissue expansion". FDA records list 3 510(k) clearances for Airxpanders, Inc., from to . As of , FDA records show no recalls naming K191138.

Clearance record

Decision date
Received
(72 days to decision)
Product code
PQN Carbon Dioxide Gas Controlled Tissue Expander
Regulation
21 CFR 878.3510
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Airxpanders, Inc. 3047 Orchard Pkwy., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQN

Trailing 12 months

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

FDA records show no clearances under product code PQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQN, 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