510(k) · Cleared

Recalled · Class II · 2014

Model 90421 Flexport Interface

K903702510(k) TraditionalCleared Oct 19, 199080-day reviewClass II21 CFR 870.2700Recalls 1

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

Cleared on Oct 19, 1990 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.

Decided: Oct 19, 1990
Review: 80 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 0

8 later devices descend from it, 2 citing it directly.

This deviceK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990
Descendant · cites it directly · 5 of its ownK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
Descendant · 2 generations on · 3 of its ownK020524 Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
Descendant · 3 generations on · 2 of its ownK031760 Viewpoint Telemetry SystemDatascope Corp. · 2003 · Recalled
Descendant · 4 generations on · 1 of its ownK142601 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · Recalled
Descendant · cites it directly · 1 of its ownK963633 Ventnet; Central Monitoring StationPuritan Bennett Corp. · 1996

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1996high 1 (1996) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all

K962473(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…Data Critical Corporation · 1997 · cites it directly5descendants
K020524Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on3descendants
K031760Viewpoint Telemetry SystemDatascope Corp. · 2003 · 3 generations on2descendants
K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. · 2014 · 4 generations on1descendant
K963633Ventnet; Central Monitoring StationPuritan Bennett Corp. · 1996 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903702	Model 90421 Flexport Interface	Spacelabs, Inc.	1990	—
+1	K962473	(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…	Data Critical Corporation	1997	—
+2	K020524	Patientnet Monitoring System	General Electric Medical Systems Information Techn	2002	1
+3	K031760	Viewpoint Telemetry System	Datascope Corp.	2003	5
+4	K142601	Panorama Patient Monitoring Network	Shenzhen Mindray Bio-Medical Electronics Co.	2014	1
+1	K963633	Ventnet; Central Monitoring Station	Puritan Bennett Corp.	1996	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
2002	1	0
2003	1	0
2005	1	0
2014	1	0
2015	1	0

FIG. 1 — Lineage of K903702, 1990–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DQA? 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 DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (8)

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

Number	Device	Applicant	Decided	Descendants
K962473	(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…	Data Critical Corporation	1997	5
K963633	Ventnet; Central Monitoring Station	Puritan Bennett Corp.	1996	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2014	Class II	Z-1824-2014	Component change control	Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K962473 (Data Critical Corporation, 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

https://510kreport.com/device/K903702 · printed Nov 5, 2026

Cite this page

510(k) Report. “K903702: Model 90421 Flexport Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903702

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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