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510(k) K951423

ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT by Impact Instrumentation, Inc. — Product Code BTA

K951423 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT". The FDA issued a decision of Substantially Equivalent on April 18, 1995. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1995
Date Received
March 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Impact Instrumentation, Inc.

  • K133196 — IMPACT MODEL 323 ASPIRATOR (March 10, 2014)
  • K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (February 16, 2012)
  • K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (April 7, 2011)
  • K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (August 13, 2009)
  • K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (December 10, 2008)
  • K051476 — UNI-VENT MODEL 73X (October 28, 2005)
  • K032386 — UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (March 26, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K941096 — ELECTRIC VACUM PUMP (January 5, 1995)
  • K931473 — IMPACT MODEL 753 (December 30, 1994)

Other clearances for product code BTA

  • K253629 — Momcozy Nasal Aspirator (BN007) (May 26, 2026)
  • K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN (May 15, 2026)
  • K260892 — Suction Pump (SU-90) (May 14, 2026)
  • K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (May 12, 2026)
  • K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (April 14, 2026)
  • K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (March 13, 2026)
  • K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (June 6, 2025)
  • K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 (May 16, 2025)
  • K251101 — AIRO Suction Unit (AIRO-01) (April 26, 2025)
  • K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) (April 23, 2025)

FDA data resources