510(k) Report

510(k) · Cleared

Cleared

Crit-Scan II Monitor

K983551510(k) TraditionalCleared May 27, 1999230-day reviewClass II21 CFR 864.5600

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

In-Line Diagnostics Corp. · GKF Instrument, Hematocrit, Automated

Cleared on May 27, 1999 as substantially equivalent to K910077 (Noninvasive Medical Technology Corp., 1992) after a 230-day review. Its family tree reaches back 1 generation to 1992.

Decided
May 27, 1999
Review
230 days
Class
Class II
Product code
GKF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K910077 (1992). No later device cites it as a predicate yet.

K910077 · Crit-Scan · Noninvasive Medical Technology Corp. · 1992199019921994199619982000
K910077 · Crit-Scan · Noninvasive Medical Technology Corp. · 19920
  1. Root · 1 generation backK910077 Crit-ScanNoninvasive Medical Technology Corp. · 1992
  2. This deviceK983551 Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910077Crit-ScanNoninvasive Medical Technology Corp.1992—
0 (this device)K983551Crit-Scan II MonitorIn-Line Diagnostics Corp.1999—
FIG. 1 — Lineage of K983551, 1992–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K910077Crit-Scan
Summary page 1
…evice which the submitter claims equivalence: The CRIT-SCAN II is an improvement to its predecessor, the CRIT-SCAN, which received 510 (K) approval in April 1992 (see # K910077). In the CRIT-SCAN 510 (K) submission, IDC claimed an accuracy level of £ 3 HCT% as compared to the microcentrifugation method of…
Noninvasive Medical Technology Corp.1992—

Also cleared against K910077: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K910077.

How does its category compare?

All GKF devices

GKF Instrument, Hematocrit, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKF

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKF

Too few GKF 510(k)s in any year since 2007 to give a median.

Recalls per year · GKF

No recall names GKF since 2007.

Adverse event reports per year · GKF

2in 2017

2009: 22010: 12017: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code GKF, 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—00
20080—00
20090—02
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device.

NOTE: The CRIT-SCAN II is not for pediatric use,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K910077

1 other device cites the same predicate.

  • K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd. · 2010

More from In-Line Diagnostics Corp.

8 FDA decisions under this applicant name. See the company

  • K001763Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 2000
  • K992227Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1999
  • K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
  • K972470Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997
  • K953875Crit-Line Hematocrit Alert (Modification)In-Line Diagnostics Corp. · 1996

Recent decisions in GKF

The GKF category page

  • K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin…Instrumentation Laboratory CO · 2016
  • K981425Stat Profile Ultra a, B, C, D, and E AnalyzersNova Biomedical Corp. · 1998
  • K981427Stat Profile M AnalyzerNova Biomedical Corp. · 19981 recall
  • K981426Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersNova Biomedical Corp. · 1998
  • K953519Microspin 24Vulcon Technologies · 1995

https://510kreport.com/device/K983551 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983551: Crit-Scan II Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983551

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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