Home / 510(k) Clearances / K981249

510(k) K981249

METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D by Instrumentation Industries, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1998
Date Received
April 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Instrumentation Industries, Inc.

  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K162753 — RTC 26-C Inline Aerosol Adapter (February 28, 2017)
  • K113644 — PILOT TUBE REPAIR KIT (January 26, 2012)
  • K102127 — ENDOTRACHEAL TUBE CHANGERS (August 27, 2010)
  • K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (July 22, 2010)
  • K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI AD (December 2, 2009)
  • K081778 — NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (September 12, 2008)
  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • K991355 — METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (January 27, 2000)
  • K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (September 17, 1999)

Other clearances for product code CAF

  • K251572 — eRapid with eTrack System (December 19, 2025)
  • K251659 — Mesh Nebulizer (H6) (November 14, 2025)
  • K244035 — Portable mesh nebulizer (JM821) (September 19, 2025)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250022 — HeroTracker Sense (June 30, 2025)
  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
  • K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (April 10, 2024)