510(k) · Cleared

Cleared

Esophageal Stethoscope W/Temp Sensor/Gastric Suct

K914887510(k) TraditionalCleared May 8, 1992191-day reviewClass II21 CFR 876.5980

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

Cleared on May 8, 1992 after a 191-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: May 8, 1992
Review: 191 days
Class: Class II
Product code: FRQ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK914887 Esophageal Stethoscope W/Temp Sensor/Gastric SuctMallinckrodt Medical · 1992
Descendant · cites it directly · 0 of its ownK022558 NGTMedical Innovative Products · 2003

Most influential descendants

Showing 1 of 1 · See all

K022558NGTMedical Innovative Products · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914887	Esophageal Stethoscope W/Temp Sensor/Gastric Suct	Mallinckrodt Medical	1992	—
+1	K022558	NGT	Medical Innovative Products	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K914887, 1992–2003Source: 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 FRQ? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K022558	NGT	Medical Innovative Products	2003	0

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?

Of its descendants, K022558 (Medical Innovative Products, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRQ devices

FRQ Tube, Levine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRQ

FDA has decided no FRQ device since 2007.

Median 510(k) review, days · FRQ

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

Recalls per year · FRQ

No recall names FRQ since 2007.

Adverse event reports per year · FRQ

No MAUDE report names FRQ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K914887 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914887: Esophageal Stethoscope W/Temp Sensor/Gastric Suct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914887

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026