510(k) · Cleared

Recalled · 2009

Tidal Wave SP Model 710/715 and 715

K032971510(k) TraditionalCleared Aug 26, 2004339-day reviewClass II21 CFR 870.2700Recalls 7

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

Respironics Novametrix, Inc. · DQA Oximeter

Cleared on Aug 26, 2004 as substantially equivalent to K963327 (Novametrix Medical Systems, Inc., 1996) and 2 other predicates after a 339-day review. Its family tree reaches back 1 generation to 1992. 1 of the 61 devices in its family, counting itself, has a Class I recall. 57 later devices descend from it. It has been recalled 7 times.

Decided: Aug 26, 2004
Review: 339 days
Class: Class II
Product code: DQA
Recalls: 7
Predicates: 3

Its longest line of descent runs back 1 generation to K920379 (1992). 3 ancestors in all. 57 later devices descend from it, 4 citing it directly. 1 of the 61 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK920379 Novametrix Model 7100 Comb. End Tidal CO2 & Pul OXNovametrix Medical Systems, Inc. · 1992 · Recalled
This deviceK032971 Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004
Descendant · cites it directly · 39 of its ownK083821 Vital Signs MonitorEdan Instruments, Inc. · 2009
Descendant · 2 generations on · 16 of its ownK093016 Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010
Descendant · 2 generations on · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
Descendant · cites it directly · 15 of its ownK042601 Capnostat 5Respironics Novametrix, Inc. · 2004 · Recalled
Descendant · 3 generations on · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2004high 5 (2018) · low 0 (2005)2026

Class I recalls in this family

K193058 SonarMed AirWave Airway Monitoring System3 generations on · 2020

Most influential descendants

Showing 5 of 57 · See all

K083821Vital Signs MonitorEdan Instruments, Inc. · 2009 · cites it directly39descendants
K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010 · 2 generations on16descendants
K113623Patient MonitorEdan Instruments, Inc. · 2012 · 2 generations on15descendants
K042601Capnostat 5Respironics Novametrix, Inc. · 2004 · cites it directly15descendants
K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920379	Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX	Novametrix Medical Systems, Inc.	1992	3
0 (this device)	K032971	Tidal Wave SP Model 710/715 and 715	Respironics Novametrix, Inc.	2004	—
+1	K083821	Vital Signs Monitor	Edan Instruments, Inc.	2009	—
+2	K093016	Vital Signs Monitor	Shenzhen Creative Industry Co., Ltd.	2010	—
+2	K113623	Patient Monitor	Edan Instruments, Inc.	2012	2
+1	K042601	Capnostat 5	Respironics Novametrix, Inc.	2004	1
+3	K131971	IM60/IM70 Patient Monitor	Edan Instruments, Inc.	2014	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2008	2	0
2009	1	0
2010	4	0
2011	2	0
2012	4	0
2013	3	0
2014	2	0
2015	1	0
2016	4	0
2017	2	0
2018	5	0
2019	1	0
2020	4	1
2021	4	0
2022	5	0
2023	3	0
2024	4	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K032971, 1992–2026Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K963327	Tidal Wave Carbon Dioxide Monitor, Model 610 Summary page 1 …ly published accuracy specifications with the specified predicate devices. The predicate devices are as follows: 1. Tidal Wave Model 610 (510(k) No. K963327) dated 11/20/1996 2. C0 2SMO, Model 7100 (510(k) No. K920379/A), dated 07/15/1992 3. Spot Check Model 510 (51…	Novametrix Medical Systems, Inc.	1996	4
*	K920379	Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX Summary page 1 …cate devices. The predicate devices are as follows: 1. Tidal Wave Model 610 (510(k) No. K963327) dated 11/20/1996 2. C0 2SMO, Model 7100 (510(k) No. K920379/A), dated 07/15/1992 3. Spot Check Model 510 (510(k) No. K924626), dated 12/03/1993. e. Device Description…	Novametrix Medical Systems, Inc.	1992	3
*	K924626	Novametrix Model 510 Summary page 1 …e Model 610 (510(k) No. K963327) dated 11/20/1996 2. C0 2SMO, Model 7100 (510(k) No. K920379/A), dated 07/15/1992 3. Spot Check Model 510 (510(k) No. K924626), dated 12/03/1993. e. Device Description The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph…	Novametrix Medical Systems, Inc.	1993	—

Also cleared against K963327: 3 other devices →

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K083821	Vital Signs Monitor	Edan Instruments, Inc.	2009	39
K042601	Capnostat 5	Respironics Novametrix, Inc.	2004	15
K092611	Sonarmed Airway Monitoring System, Model 0901	Sonarmed, Inc.	2010	2
K123797	NT1D Vital Signs Monitor	New Tech, Inc.	2013	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2009	Not classified	Z-1279-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1278-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1292-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1276-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1290-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1277-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009	Not classified	Z-1263-2010	Nonconforming Material/Component	Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…

The 5 latest of 7 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K083821 (Edan Instruments, Inc., 2009) has gone furthest, with 39 descendants of its own.
3 other devices also cite its predicate K963327.

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?

The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU). and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032971: Tidal Wave SP Model 710/715 and 715.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032971

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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