510(k) Report

510(k) · Cleared

Cleared

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

K171476510(k) TraditionalCleared Feb 27, 2018284-day reviewClass II21 CFR 862.1665

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Awareness Technology, Inc. · JGS Electrode, Ion Specific, Sodium

Cleared on Feb 27, 2018 as substantially equivalent to K961458 (Avl Scientific Corp., 1996) after a 284-day review. Its family tree reaches back 2 generations to 1986.

Decided
Feb 27, 2018
Review
284 days
Class
Class II
Product code
JGS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K861087 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 1 other ancestor1986: 1 other ancestorK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 1986K961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalled19851990199520002005201020152020
Other ancestors, by generation 2 generations back: 2 other ancestors K961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalledK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 19860
  1. Root · 2 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
  2. 1 generation backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
  3. This deviceK171476 SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K861087Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp.1986—
−1K961458Avl 9180 Electrolyte AnalyzerAvl Scientific Corp.19961
0 (this device)K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
FIG. 1 — Lineage of K171476, 1986–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JGS device

  1. #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K961458Avl 9180 Electrolyte Analyzer
Summary page 4
…For Clinical Use Substantial Equivalence Awareness Technology is claiming substantial equivalence to the predicate device, AVL 9180 Electrolyte Analyzer, 510(k) number K961458. Description The SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an automated, microprocessor-controlled electrolyte analyze…
Avl Scientific Corp.19961

Also cleared against K961458: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K961458.

How does its category compare?

All JGS devices

JGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · JGS

3in 2023

2008: 22009: 22010: 12011: 32012: 12013: 22014: 12015: 12016: 42017: 12018: 32019: 32020: 22022: 12023: 32026 (partial year): 1
2007high 4 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGS

347in 2023

2011: 191 days median2016: 198 days median2018: 180 days median2019: 58 days median2023: 347 days median
2007high 347 (2023) · low 58 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JGS

4in 2023

2007: 72008: 12010: 12011: 12012: 22013: 52015: 12019: 52020: 12021: 12023: 4
2007high 7 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JGS

64in 2025

2007: 332008: 32009: 572010: 3612011: 9122012: 4122013: 5102014: 2512015: 1582016: 842017: 2922018: 1582019: 1052020: 892021: 912022: 602023: 982024: 962025: 64
2007high 912 (2011) · low 3 (2008)2025

MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—733
20082—13
20092—057
20101—1361
201131911912
20121—2412
20132—5510
20141—0251
20151—1158
20164198084
20171—0292
201831800158
20193585105
20202—189
20210—191
20221—060
20233347498
20240—096
20250—064
20261—0—

What is it indicated for?

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use only. The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device…

Read the full statement (168 words)

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of

ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples.

The measurements are to be conducted by a trained professional in a clinical laboratory.

For in-vitro diagnostic use only.

The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to

monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension,

Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte

imbalance.

The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to

monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood

potassium levels.

The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and

treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Indications for use as stated in the FDA summary.

Also cleared against K961458

5 other devices cite the same predicate.

  • K121040Smartlyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012
  • K082462Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009
  • K070104Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2008
  • K023792Calibration Pack, Models A9100-101S and A9100-103SThermo Orion · 2003
  • K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 19977 recalls

More from Awareness Technology, Inc.

18 FDA decisions under this applicant name. See the company

  • K013420Chemwell, Also Known as Project 2900Awareness Technology, Inc. · 2002
  • K010877Chemwell, Model 2900Awareness Technology, Inc. · 2001
  • K974762Stat TracksAwareness Technology, Inc. · 1998
  • K943729Dye Check Strips 545-630Awareness Technology, Inc. · 1994
  • K941394Stat Fax 2600Awareness Technology, Inc. · 1994

Recent decisions in JGS

The JGS category page

  • K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
  • K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023
  • K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 20237 recalls
  • K213486GLP systems TrackAbbott Laboratories · 2022

https://510kreport.com/device/K171476 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171476: SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171476

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026