510(k) Report

FDA applicant

Sendx Medical, Inc.

Carlsbad, CA6 decisions1997–201511 recalls

FDA records 6 decisions for Sendx Medical, Inc. (Carlsbad, CA) from 1997 to 2015: 6 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and CGA (Glucose Oxidase, Glucose). Its devices cite 13 predicates, 3 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Sendx Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2008: 12015: 2
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2020

2007: 22009: 12010: 12012: 22015: 12016: 12018: 12020: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Sendx Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sendx Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph4decisions
  • CGAGlucose Oxidase, Glucose1decision
  • CGZElectrode, Ion-Specific, Chloride1decision

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051804ABL80 Flex AnalyzerSendx Medical, Inc. · 20051cites it
  • K080370Abl 80 CO-OX SystemSendx Medical, Inc. · 20081cites it
  • K994346Abl 77 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 20001cites it

What has FDA decided for it lately?

  • K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc. · 2015
  • K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 20153 recalls
  • K080370Abl 80 CO-OX SystemSendx Medical, Inc. · 20084 recalls
  • K051804ABL80 Flex AnalyzerSendx Medical, Inc. · 20054 recalls
  • K994346Abl 77 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 20001 recall
  • K973742Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 1997

All 6 as Sendx Medical, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K051804ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage…May 11, 2020Class II
  • K080370ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product…May 11, 2020Class II
  • K130144AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to…Feb 27, 2018Class II
  • K130144AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0…Nov 23, 2016Class II
  • K130144AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay…Dec 29, 2015Class II
  • K051804ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood…Jun 6, 2012Class II