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510(k) K882121

C-FLO SUCTION TUBE by Concept, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood Pressure Cuff
Device Class
Class II
Regulation Number
870.1120
Review Panel
CV
Submission Type

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Other clearances by Concept, Inc.

  • K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE (May 1, 1992)
  • K912957 — CONCEPT MICROMILL (October 4, 1991)
  • K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (June 5, 1990)
  • K894929 — STAPLE FIXATION SYSTEM (August 30, 1989)
  • K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (August 1, 1989)
  • K891109 — PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (May 8, 1989)
  • K881954 — CONCEPT POWER SYSTEM (November 9, 1988)
  • K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (November 8, 1988)
  • K880414 — TENDON HARVESTER (March 25, 1988)
  • K874676 — INTERFERENCE SCREW (March 7, 1988)

Other clearances for product code DXQ

  • K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-12 (February 13, 2026)
  • K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) (January 9, 2026)
  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
  • K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
  • K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
  • K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
  • K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
  • K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 (November 29, 2023)
  • K231961 — NIBPCuff (August 30, 2023)