510(k) Report

510(k) · Cleared

Cleared

Avl Model 995HB PH/Blood Gas Analyzer

K895317510(k) TraditionalCleared Feb 1, 1990156-day reviewClass II21 CFR 862.1120

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

Avl Scientific Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Cleared on Feb 1, 1990 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Feb 1, 1990
Review
156 days
Class
Class II
Product code
CHL
Recalls
None
Predicates
0

16 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared1996: 2 descendants cleared1998: 2 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared1999: 1 descendant cleared2013: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK895317 Avl Model 995HB PH/Blood Gas AnalyzerAvl Scientific Corp. · 1990
  2. Descendant · cites it directly · 7 of its ownK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
  3. Descendant · cites it directly · 6 of its ownK961161 Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp. · 1996
  4. Descendant · 2 generations on · 5 of its ownK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · Recalled
  5. Descendant · cites it directly · 5 of its ownK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  6. Descendant · 3 generations on · 4 of its ownK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1996: 21998: 21999: 12005: 22010: 12011: 12013: 22020: 12021: 12023: 22025: 1
1996high 2 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 16 · See all
  • K050423Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005 · cites it directly7descendants
  • K961161Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp. · 1996 · cites it directly6descendants
  • K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · 2 generations on5descendants
  • K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly5descendants
  • K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895317Avl Model 995HB PH/Blood Gas AnalyzerAvl Scientific Corp.1990—
+1K050423Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics2005—
+1K961161Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp.1996—
+2K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps20112
+1K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.1998—
+3K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
199910
200520
201010
201110
201320
202010
202110
202320
202510
FIG. 1 — Lineage of K895317, 1990–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CHL? 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 CHL device

  1. #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050423Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics20057
K961161Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp.19966
K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985
K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984
K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.20050
K963964Avl Compact 3 PH/Blood Gas AnalyzerAvl Scientific Corp.19960

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?

  • Of its descendants, K050423 (Roche Diagnostics, 2005) has gone furthest, with 7 descendants of its own.

How does its category compare?

All CHL devices

CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHL

1in 2025

2007: 12008: 12010: 12011: 42012: 42013: 52014: 32015: 42016: 32017: 12018: 12020: 42021: 22023: 52024: 12025: 12026 (partial year): 1
2007high 5 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHL

267in 2023

2011: 108 days median2012: 65 days median2013: 152 days median2014: 68 days median2015: 155 days median2016: 306 days median2020: 100 days median2023: 267 days median
2007high 306 (2016) · low 65 (2012)2026

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

Recalls per year · CHL

13so far in 2026, the most since 2007

2007: 62008: 52009: 62010: 72011: 12012: 92013: 12014: 12015: 32016: 12017: 12018: 32020: 22023: 42024: 92026 (partial year): 13
2007high 13 (2026) · low 0 (2019)2026

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

Adverse event reports per year · CHL

210in 2025

2007: 162008: 402009: 742010: 202011: 502012: 642013: 622014: 932015: 552016: 1182017: 2062018: 1742019: 1412020: 1172021: 1472022: 1382023: 1772024: 1962025: 210
2007high 210 (2025) · low 16 (2007)2025

MAUDE reports naming product code CHL, 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
20071—616
20081—540
20090—674
20101—720
20114108150
2012465964
20135152162
2014368193
20154155355
201633061118
20171—1206
20181—3174
20190—0141
202041002117
20212—0147
20220—0138
202352674177
20241—9196
20251—0210
20261—13—

More from Avl Scientific Corp.

33 FDA decisions under this applicant name. See the company

  • K001632Opti-Check Plus Multi-Analyte Control, Model HC7009Avl Scientific Corp. · 2000
  • K000103Avl Opti R AnalyzerAvl Scientific Corp. · 2000
  • K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
  • K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 19994 recalls
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998

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https://510kreport.com/device/K895317 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895317: Avl Model 995HB PH/Blood Gas Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895317

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026