510(k) · Cleared

Recalled · Class II · 2022

Pico Models 30, 50, 70

K962158510(k) TraditionalCleared Oct 29, 1996147-day reviewClass II21 CFR 862.1675Recalls 1

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

Radiometer America, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Oct 29, 1996 as substantially equivalent to K896514 (Radiometer America, Inc., 1990) after a 147-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it. It has been recalled once.

Decided: Oct 29, 1996
Review: 147 days
Class: Class II
Product code: JKA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K896514 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK896514 QS90 Smooth E Arterial Blood SamplerRadiometer America, Inc. · 1990
This deviceK962158 Pico Models 30, 50, 70Radiometer America, Inc. · 1996
Descendant · cites it directly · 0 of its ownK043143 SafepicoRadiometer Medical Aps · 2005 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K043143SafepicoRadiometer Medical Aps · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896514	QS90 Smooth E Arterial Blood Sampler	Radiometer America, Inc.	1990	—
0 (this device)	K962158	Pico Models 30, 50, 70	Radiometer America, Inc.	1996	—
+1	K043143	Safepico	Radiometer Medical Aps	2005	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K962158, 1990–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JKA? 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 JKA device

#1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K896514	QS90 Smooth E Arterial Blood Sampler Summary page 1 …line. SUBSTANTIAL EQUIVALENCE: The PICO product line is substantially equivalent in features, intended use, and characteristics to the current Smooth’ E™ product line (K896514) marketed by Radiometer America Inc. The significant difference from Smooth E™ to the new PICO design is the addition of metabol…	Radiometer America, Inc.	1990	—

Also cleared against K896514: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043143	Safepico	Radiometer Medical Aps	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 8, 2022	Class II	Z-1115-2022	Package design/selection	Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K043143 (Radiometer Medical Aps, 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K896514.

How does its category compare?

All JKA devices

JKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKA

7in 2025

2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007high 281 (2007) · low 28 (2010)2026

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

Recalls per year · JKA

13in 2025

2007high 14 (2011) · low 0 (2020)2026

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

Adverse event reports per year · JKA

6,089in 2025

2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, 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	4	281	3	73
2008	2	—	3	78
2009	2	—	3	42
2010	4	28	4	37
2011	0	—	14	67
2012	1	—	2	54
2013	3	244	1	33
2014	1	—	1	68
2015	1	—	6	41
2016	4	116	1	65
2017	2	—	2	2,039
2018	1	—	2	9,731
2019	6	181	9	6,469
2020	6	181	0	3,774
2021	4	217	3	3,610
2022	9	164	2	3,375
2023	17	189	2	4,400
2024	6	240	0	4,609
2025	7	115	13	6,089
2026	8	250	1	—

What is it indicated for?

Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.

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

https://510kreport.com/device/K962158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962158: Pico Models 30, 50, 70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962158

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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