510(k) · Cleared

Cleared

Non-Sterile Ors-400N Scope Pillow Warmer Drape

K142173510(k) TraditionalCleared Dec 30, 2014145-day reviewClass I21 CFR 890.5950

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

Ecolab, Inc. · LHC Warmer, Irrigation Solution

Cleared on Dec 30, 2014 as substantially equivalent to K021288 (O.R. Solutions, Inc., 2002) and 1 other predicate after a 145-day review. Its family tree reaches back 2 generations to 1999.

Decided: Dec 30, 2014
Review: 145 days
Class: Class I
Product code: LHC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K990334 (1999). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990334 Ksea Endoscope HolderKARL STORZ Endoscopy-America, Inc. · 1999
1 generation backK051979 Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005
This deviceK142173 Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990334	Ksea Endoscope Holder	KARL STORZ Endoscopy-America, Inc.	1999	—
−1	K051979	Ors Model 6000 Endoscope Holder	O.R. Solutions, Inc.	2005	—
0 (this device)	K142173	Non-Sterile Ors-400N Scope Pillow Warmer Drape	Ecolab, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K142173, 1999–2014Source: 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 LHC? 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? (2)

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
*	K021288	ORS-1000LD Summary page 4 …s: No Recognized Consensus Standards Predicate Device: ORS Warming Drape cleared on 06/27/2002 via K021288 and ORS Endoscope Holder cleared on 08/30/2005 via K051979 CONFIDENTIAL…	O.R. Solutions, Inc.	2002	1
*	K051979	Ors Model 6000 Endoscope Holder Summary page 4 …ming Drape cleared on 06/27/2002 via K021288 and ORS Endoscope Holder cleared on 08/30/2005 via K051979 CONFIDENTIAL 5-1 Ecolab Inc.…	O.R. Solutions, Inc.	2005	—

Also cleared against K021288: 2 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 15 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K021288.

How does its category compare?

All LHC devices

LHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · LHC

2in 2016

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHC

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

Recalls per year · LHC

8in 2015

2007high 8 (2015) · low 0 (2007)2026

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

Adverse event reports per year · LHC

6in 2025

2007high 69 (2016) · low 0 (2023)2025

MAUDE reports naming product code LHC, 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	0	—	0	3
2008	1	—	0	5
2009	1	—	0	2
2010	0	—	0	1
2011	0	—	0	2
2012	0	—	0	5
2013	0	—	0	2
2014	2	—	0	4
2015	1	—	8	13
2016	2	—	0	69
2017	0	—	0	33
2018	0	—	0	30
2019	0	—	0	8
2020	0	—	0	4
2021	0	—	0	5
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	5
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

The ORS pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The following model(s) are included: ORS-400 and ORS-400N

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142173: Non-Sterile Ors-400N Scope Pillow Warmer Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142173

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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