510(k) · Cleared

Cleared

Pulse Oximeter Adapter Cables

K052544510(k) AbbreviatedCleared Sep 29, 2006379-day reviewClass II21 CFR 870.2700

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

American I.V. Products, Inc. · DQA Oximeter

Cleared on Sep 29, 2006 as substantially equivalent to K001020 (Criticare Systems, Inc., 2000) and 9 other predicates after a 379-day review. Its family tree reaches back 4 generations to 1997.

Decided: Sep 29, 2006
Review: 379 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 15

Its longest line of descent runs back 4 generations to K962603 (1997). 45 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
This deviceK052544 Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−3	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−2	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−1	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
0 (this device)	K052544	Pulse Oximeter Adapter Cables	American I.V. Products, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1985	1	0
1986	1	0
1989	1	0
1990	3	0
1991	2	0
1993	2	0
1994	5	0
1995	4	0
1996	6	0
1997	5	0
1998	2	0
1999	2	0
2000	3	0
2002	1	0
2003	2	0

FIG. 1 — Lineage of K052544, 1997–2006Source: 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 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? (15)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K001020	8100 Vital Signs Monitor Summary page 1 …Proprietary Name: Pulse Oximeter Adapter Cables Predicate Device: These AlIV devices are equivalent to the following legally marketed devices: Criticare Model: 518DD- K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2…	Criticare Systems, Inc.	2000	—
*	K934959	Model 118 Fetal/Maternal Monitor Summary page 1 …ter Cables Predicate Device: These AlIV devices are equivalent to the following legally marketed devices: Criticare Model: 518DD- K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilco…	Ge Medical Systems Information Technologies	1994	—
Kept off the family tree	K097006	Datascope Model 0012-00-0516-02 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K993531	Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX Summary page 1 …uivalent to the following legally marketed devices: Criticare Model: 518DD- K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(97…	Datascope Corp.	2000	1
Kept off the family tree	K012467	FDA’s K012467 is Solar 8000M System Our reading of the summary gave K012467, FDA’s number for Solar 8000M System (General Electric Medical Systems Information Techn). Its FDA name has none of the distinctive words the summary uses for the device it names, “GE Medical Systems Models E9004GE and 2006644-001”. Kept off the family tree. Summary page 1 …icare Model: 518DD- K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phill…	General Electric Medical Systems Information Techn	2002	2
*	K033304	Modification to Dash 3000/4000 Patient Monitor Summary page 1 …l: 518DD- K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model:…	Ge Medical Systems Information Technologies	2003	1
*	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
*	K993637	N-395 Pulse Oximeter, with Extended Device Claims Summary page 1 …l: 4033CAX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model: M1940A-K1(14159 Phillips Model:…	Nellcor Puritan Bennett, Inc.	1999	1
*	K973147	NPB-295 Pulse Oximeter Summary page 1 …AX - K934959 Datascope Model: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model: M1940A-K1(14159 Phillips Model: M1941A -K…	Nellcor Puritan Bennett, Inc.	1997	1
*	K971946	NPB-190 Pulse Oximeter (NPB-190) Summary page 1 …del: 001 2-00-0516-02 - K(97006 & K(993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Neilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model: M1940A-K1(14159 Phillips Model: M1941A -K1993383 Phillips Model:…	Nellcor Puritan Bennett, Inc.	1997	—
Kept off the family tree	K014159	FDA’s K014159 is Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Philips Medical Systems, Inc.	2002	—
Kept off the family tree	K993383	FDA’s K993383 is HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models… Our reading of the summary gave K993383, FDA’s number for HP Viridia Multi-Measurement Server/Compact Portable… (Hewlett-Packard GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Model M1941A”. Kept off the family tree. Summary page 1 …ilcor MC1O0-K1991 823,K1993637 &K973147 Neilcor DEC8 - K(971946 Nellcor: SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model: M1940A-K1(14159 Phillips Model: M1941A -K1993383 Phillips Model: M1943A -K1(21453 Spacelabs Model: 700-0002-00 - K(901209 Spacelabs Model: 700-0030-00 - K(972502 S~acelabs; Model…	Hewlett-Packard GmbH	2000	2
Kept off the family tree	K021453	FDA’s K021453 is Heartstream XL Defibrillator/Monitor, Model #M4735A Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Philips Medical Systems	2002	8
*	K901209	Model 90489 Pulse Oximeter Module Summary page 1 …SCP1O - K(99 1823, K(993637 & K(973147 Phillips Model: M1940A-K1(14159 Phillips Model: M1941A -K1993383 Phillips Model: M1943A -K1(21453 Spacelabs Model: 700-0002-00 - K(901209 Spacelabs Model: 700-0030-00 - K(972502 S~acelabs; Model: 175-0646-00 - K(901209 Soacelabs Model: 700-0029-00 -K1972502 Descript…	Spacelabs, Inc.	1990	—
*	K972502	Spacelabs Medical Integrated Multiparameter Module 90496 Summary page 1 …hillips Model: M1940A-K1(14159 Phillips Model: M1941A -K1993383 Phillips Model: M1943A -K1(21453 Spacelabs Model: 700-0002-00 - K(901209 Spacelabs Model: 700-0030-00 - K(972502 S~acelabs; Model: 175-0646-00 - K(901209 Soacelabs Model: 700-0029-00 -K1972502 Description: AIV's Pulse Oximeter Adapter Cables…	Spacelabs Medical, Inc.	1998	3

Also cleared against K001020: 4 other devices →

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?

The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 11 months on median.
11 of the 45 ancestors have a recall of any class.
4 other devices also cite its predicate K001020.

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	—

What is it indicated for?

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052544: Pulse Oximeter Adapter Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052544

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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