Atlas FDA

JPI

15 FDA 510(k) clearances · Product code

47 daysmedian time to decision
266 days90th percentile
15clearances measured

FDA profile

Official device name
Device, Hematocrit Measuring
Device class
Class II (moderate risk)
Regulation
21 CFR 864.6400
Medical specialty
Hematology
Adverse events (MAUDE)
2000: 2 · 2024: 17 · 2025: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183680)Abbott Point of Care, Inc.2020-02-28
i-STAT Hematocrit test with i-STAT Alinity System (K163342)Abbott Laboratories2017-08-22
CRIT-LINE HEMATOCRIT ALERT (K950942)In-Line Diagnostics Corp.1995-03-14
CRIT-LINE (K924167)Noninvasive Medical Technology Corp.1993-05-07
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (K903698)Statspin Technologies1990-09-17
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (K902028)Norfolk Scientific, Inc.1990-06-20
CHART-TYPE MICRO HEMATOCRIT TUBE READER (K870511)Norfolk Scientific, Inc.1987-03-16
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (K852482)Em Diagnostic Systems, Inc.1985-07-15
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (K852516)Whittaker General Medical1985-07-15
PLASMA EXTRACTION SYSTEM (K850391)Hans J. Brouwers & Assoc.1985-05-10
HAEMOFUGE A. BIOFUGE A. & B (K840767)Heraeus-Christ GmbH1984-04-17
COMPUR* M1100 HEMATRCRIT SYSTEM (K831318)Worthington Diagnostic Systems1983-06-08
MICROHEMATOCRIT READER (K830578)Fisher Scientific Co., LLC1983-03-24
MICRO-HEMATOCRIT CENTRIFUGE 335/336 (K823558)Fisher Scientific Co., LLC1983-01-21
UNIVERSAL CENTRIFUGE (K822716)Biodynamics Corp.1982-09-30

Track JPI automatically

Every clearance here is in the API, with alerts when new ones post.