510(k) · Cleared
Recalled · Class II · 2012Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · CFR Hexokinase, Glucose
Cleared on Nov 8, 2011 as substantially equivalent to K052007 (Horiba Abx, 2005) after a 316-day review. Its family tree reaches back 4 generations to 1994. It has been recalled once.
- Decided
- Nov 8, 2011
- Review
- 316 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933930 (1994). 13 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- Root · 4 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 3 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 2 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 1 generation backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- This deviceK103788 Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentHoriba Abx Sas · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −3 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −2 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −1 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| 0 (this device) | K103788 | Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent | Horiba Abx Sas | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
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 CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 2…submission demonstrates substantial equivalence to their respective predicate devices: Candidate device Predicate device PENTRA C200 K052007 ABX PENTRA 400 PENTRA 0200 IS.E. Module K052007 ABX PENTRA 400 IS.E. Module ABX PENTRA Glucose HK… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2012 | Class II | Z-0633-2013 | Software design | Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 8 other devices also cite its predicate K052007.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings. It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride. ABX Pentra Glucose HK CP reagent with…
Read the full statement (171 words)
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings. It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride.
ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and odiopathic hypoglycemnia, and of pancreatic islet cell carcinoma,
The IS.E. (Ion Selective Electrode) Module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiomnetry using ion selective electrode with associated reference solution, calibrators and controls, Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103788: Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103788
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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