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510(k) K881297

BARO-GRAF 24 by Instromedix, Inc. — Product Code DRS

K881297 is an FDA 510(k) premarket notification submitted by Instromedix, Inc. for the device "BARO-GRAF 24". The FDA issued a decision of Substantially Equivalent on September 16, 1988. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Instromedix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1988
Date Received
March 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by Instromedix, Inc.

  • K010945 — HEARTCARD, MODEL 5258 (June 12, 2001)
  • K964408 — POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (July 23, 1997)
  • K964036 — CARDIOMAGIC 2000 SOFTWARE (July 18, 1997)
  • K955060 — ACCELERATED TRANSMISSION PROTOCOL (April 8, 1996)
  • K951096 — LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (January 16, 1996)
  • K945476 — HEARTHWATCH III(TM) (November 9, 1995)
  • K950003 — CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (October 31, 1995)
  • K944362 — HEARTCARD CARDIAC EVENT MONITOR (September 7, 1995)
  • K943931 — CARRYALL ENHANCEMENTS (April 4, 1995)
  • K935586 — PRINCE (November 8, 1994)

Other clearances for product code DRS

  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)
  • K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (March 17, 2023)
  • K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (November 9, 2017)
  • K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (May 24, 2017)
  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)

FDA data resources