EZFLOW MAX, MODEL 1007— 510(k) K993558

Name: FDA 510(k) clearance K993558
Creator: U.S. Food and Drug Administration
Published: 1999-11-12

Substantially Equivalent

Piper Medical Products

FDA 510(k) clearance K993558 for EZFLOW MAX, MODEL 1007, Substantially Equivalent on 1999-11-12. Applicant: Piper Medical Products. Device class: 2.

Clearance details

Applicant: Piper Medical Products
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1999-10-20
Decision date: 1999-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

More clearances from Piper Medical Products

view all

K990384 — EZFLOW CONTINUOUS NEBULIZER,MODEL 10051999-04-26
K982408 — AEROTEE, MODEL # 10011998-09-14

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.