510(k) · Cleared

Cleared

Bal Cath Bronchial Aspirate Sampling Catheter

K112562510(k) TraditionalCleared Dec 15, 201180-day reviewClass I21 CFR 868.6810

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

Kimberly-Clark · OYI Non-Bronchoscopic Bronchoalveolar Lavage Catheter

Cleared on Dec 15, 2011 as substantially equivalent to K923487 (Ballard Medical Products, 1993) after an 80-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Dec 15, 2011
Review: 80 days
Class: Class I
Product code: OYI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923487 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923487 Bal CathBallard Medical Products · 1993
This deviceK112562 Bal Cath Bronchial Aspirate Sampling CatheterKimberly-Clark · 2011
Descendant · cites it directly · 0 of its ownK150280 PulmoVia Working ChannelSanovas, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K150280PulmoVia Working ChannelSanovas, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923487	Bal Cath	Ballard Medical Products	1993	—
0 (this device)	K112562	Bal Cath Bronchial Aspirate Sampling Catheter	Kimberly-Clark	2011	—
+1	K150280	PulmoVia Working Channel	Sanovas, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K112562, 1993–2015Source: 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 OYI? 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

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What was it cleared against? (1)

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
*	K923487	Bal Cath Summary page 1 …nt t BAL Oath t Bronchial Aspirate Sampling Catheter is substantially equivalent to the predicate device, BAL Cath t (K923487). Device Sterile, single use, catheter kit for performing non-bronchoscopic Description: Brochoa…	Ballard Medical Products	1993	—

Also cleared against K923487: 3 other devices →

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
K150280	PulmoVia Working Channel	Sanovas, Inc.	2015	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?

Its one ancestor has no recall.
Of its descendants, K150280 (Sanovas, Inc., 2015) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K923487.

How does its category compare?

All OYI devices

OYI Non-Bronchoscopic Bronchoalveolar Lavage Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OYI

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OYI

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

Recalls per year · OYI

No recall names OYI since 2007.

Adverse event reports per year · OYI

2in 2021

2007high 7 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	7
2020	0	—	0
2021	0	—	2
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Kimberly-Clark' KimVent' BAL CalM* Bronchial Aspirate Sampling Catheter is used in the diagnosis, of diffuse lung disease by allowing collection of bronchoalveolar lavage (GAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112562: Bal Cath Bronchial Aspirate Sampling Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112562

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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