510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170075Substantially Equivalent

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)

Airxpanders, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170075 is the FDA 510(k) clearance record for AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5), 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 K170075.

Clearance record

Decision date
Received
(84 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. 1047 Elwell Ct., Palo Alto 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