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510(k) K151856

ABL80 FLEX CO-OX with AQURE connectivity by Sendx Medical, Inc. — Product Code CHL

K151856 is an FDA 510(k) premarket notification submitted by Sendx Medical, Inc. for the device "ABL80 FLEX CO-OX with AQURE connectivity". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Sendx Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
July 8, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Sendx Medical, Inc.

  • K151639 — ABL80 FLEX and ABL80 FLEX CO-OX (December 7, 2015)
  • K080370 — ABL 80 CO-OX SYSTEM (July 31, 2008)
  • K051804 — ABL80 FLEX ANALYZER (November 1, 2005)
  • K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (February 1, 2000)
  • K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (December 3, 1997)

Other clearances for product code CHL

  • K252207 — ABL90 FLEX PLUS System, safeCLINITUBES (April 10, 2026)
  • K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K203790 — GEM Premier 5000 (August 20, 2021)
  • K200986 — OPTI® B-Lac Cassette (August 2, 2021)

FDA data resources