510(k) · Cleared

Cleared

Flowmeter, P.C., Redesigned Version

K760102510(k) TraditionalCleared Jul 16, 197623-day reviewClass I21 CFR 868.2340

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

Ohio Medical Products · CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Cleared on Jul 16, 1976 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.

Decided: Jul 16, 1976
Review: 23 days
Class: Class I
Product code: CAX
Recalls: None
Predicates: 0

13 later devices descend from it, 1 citing it directly. 6 of the 14 devices in this family, counting this one, have a Class I recall.

This deviceK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
Descendant · cites it directly · 12 of its ownK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
Descendant · 2 generations on · 10 of its ownK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
Descendant · 2 generations on · 4 of its ownK070247 Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
Descendant · 3 generations on · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
Descendant · 4 generations on · 2 of its ownK072157 Modification to Giraffe and Panda Warmers (Giraffe and Panda…Ohmeda Medical · 2007 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997high 4 (2007) · low 0 (1998)2026

Class I recalls in this family

K070247 Giraffe and Panda Bag and Mask Resuscitation…2 generations on · 2007
K070210 Giraffe and Panda T- Piece Resuscitation System2 generations on · 2007
K070377 Giraffe and Panda Warmer3 generations on · 2007
K093913 Mercury Medical T-Piece Resuscitator3 generations on · 2010

Most influential descendants

Showing 5 of 13 · See all

K971243Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997 · cites it directly12descendants
K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · 2 generations on10descendants
K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · 2 generations on4descendants
K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 3 generations on3descendants
K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 2007 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K760102	Flowmeter, P.C., Redesigned Version	Ohio Medical Products	1976	—
+1	K971243	Ohmeda Infant Resuscitation System	Ohmeda Medical	1997	—
+2	K070210	Giraffe and Panda T- Piece Resuscitation System	Ohmeda Medical	2007	Class I
+2	K070247	Giraffe and Panda Bag and Mask Resuscitation System	Ohmeda Medical	2007	Class I
+3	K070377	Giraffe and Panda Warmer	Ohmeda Medical	2007	Class I
+4	K072157	Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible…	Ohmeda Medical	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2007	4	3
2009	1	1
2010	1	1
2011	2	0
2013	1	1
2014	1	0
2018	1	0
2019	1	0

FIG. 1 — Lineage of K760102, 1976–2019Source: 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.

6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K971243	Ohmeda Infant Resuscitation System	Ohmeda Medical	1997	12

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

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.

K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K971243 (Ohmeda Medical, 1997) has gone furthest, with 12 descendants of its own.

How does its category compare?

All CAX devices

CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAX

FDA has decided no CAX device since 2007.

Median 510(k) review, days · CAX

Too few CAX 510(k)s in any year since 2007 to give a median.

Recalls per year · CAX

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CAX

4in 2025

2007high 27 (2009) · low 0 (2016)2025

MAUDE reports naming product code CAX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	5
2008	—	1	4
2009	—	0	27
2010	—	0	7
2011	—	0	13
2012	—	0	5
2013	—	0	5
2014	—	0	1
2015	—	0	2
2016	—	0	0
2017	—	0	4
2018	—	0	3
2019	—	0	6
2020	—	0	1
2021	—	0	6
2022	—	0	1
2023	—	0	3
2024	—	0	1
2025	—	0	4
2026	—	0	—

https://510kreport.com/device/K760102 · printed Nov 3, 2026

Cite this page

510(k) Report. “K760102: Flowmeter, P.C., Redesigned Version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K760102

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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