510(k) Report

510(k) · Cleared

Cleared

Ipi Humidifier Chamber

K993282510(k) TraditionalCleared Sep 18, 2000354-day reviewClass II21 CFR 868.5450

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

I.P.I. Medical Products · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

Cleared on Sep 18, 2000 as substantially equivalent to K903138 (Marquest Medical Products, Inc., 1990) and 5 other predicates after a 354-day review. Its family tree reaches back 2 generations to 1985.

Decided
Sep 18, 2000
Review
354 days
Class
Class II
Product code
BTT
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K850647 (1985). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1990: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestorK850647 · Heated Respiratory Humififier MR440 · Fisher & Paykel Allied Products, Ltd. · 1985K962223 · Water Chambers for ST 3000 Heated Humidifier · Marquest Medical Products, Inc. · 19971985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K962223 · Water Chambers for ST 3000 Heated Humidifier · Marquest Medical Products, Inc. · 1997K850647 · Heated Respiratory Humififier MR440 · Fisher & Paykel Allied Products, Ltd. · 19850
  1. Root · 2 generations backK850647 Heated Respiratory Humififier MR440Fisher & Paykel Allied Products, Ltd. · 1985
  2. 1 generation backK962223 Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
  3. This deviceK993282 Ipi Humidifier ChamberI.P.I. Medical Products · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K850647Heated Respiratory Humififier MR440Fisher & Paykel Allied Products, Ltd.1985—
−1K962223Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc.1997—
0 (this device)K993282Ipi Humidifier ChamberI.P.I. Medical Products2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
199010
199410
FIG. 1 — Lineage of K993282, 1985–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 BTT? 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 BTT device

  1. #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K903138Marquest SCT 3000, Heated Humidification System
Summary page 1
…Intended Use: Humidifier Chambers for use with Marquest SCT 3000 Heated Humidifier and Fisher & Paykel MR 700, MR720, and MR730. Predicate Devices: Marquest SCT 3000 - K903138 and K862223 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device Description: The humidifier chambers offer…
Marquest Medical Products, Inc.1990—
*K962223Water Chambers for ST 3000 Heated Humidifier
Our OCR of the scanned summary read K862223, FDA’s number for Micro Thin* Paraffin (Richard-Allan Medical Ind., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquest SCT 3000”.
Marquest Medical Products, Inc.1997—
*K864173HPD Humidifying Chamber
Summary page 1
…for use with Marquest SCT 3000 Heated Humidifier and Fisher & Paykel MR 700, MR720, and MR730. Predicate Devices: Marquest SCT 3000 - K903138 and K862223 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device Description: The humidifier chambers offered for use with the Marquest SCT 30…
Hpd Medical, Inc.1987—
*K850647Heated Respiratory Humififier MR440
Summary page 1
…3000 Heated Humidifier and Fisher & Paykel MR 700, MR720, and MR730. Predicate Devices: Marquest SCT 3000 - K903138 and K862223 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device Description: The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR7…
Fisher & Paykel Allied Products, Ltd.1985—
*K862923MR620 Dual Servo Heated Anaesthesia Humidifier
Summary page 1
…ed Humidifier and Fisher & Paykel MR 700, MR720, and MR730. Predicate Devices: Marquest SCT 3000 - K903138 and K862223 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device Description: The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR700, MR720…
Fisher & Paykel Allied Products, Ltd.1986—
*K934140MR290 Humidification Chamber Single Use
Summary page 1
…ifier and Fisher & Paykel MR 700, MR720, and MR730. Predicate Devices: Marquest SCT 3000 - K903138 and K862223 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device Description: The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR700, MR720, and MR7…
Fisher & Paykel Electronics, Ltd.1994—

Also cleared against K903138: 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 11.8 years on median.
  • None of the 6 ancestors has a recall.
  • 2 other devices also cite its predicate K903138.

How does its category compare?

All BTT devices

BTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTT

4in 2025

2007: 62008: 42009: 12010: 42011: 32012: 22013: 62014: 72015: 12016: 32017: 32018: 22019: 12020: 22021: 22022: 32023: 72024: 72025: 42026 (partial year): 4
2007high 7 (2014) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTT

104in 2025

2007: 73 days median2008: 199 days median2010: 113 days median2011: 116 days median2013: 171 days median2014: 231 days median2016: 157 days median2017: 303 days median2022: 290 days median2023: 258 days median2024: 219 days median2025: 104 days median2026 (partial year): 184 days median
2007high 303 (2017) · low 73 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTT

1in 2025

2007: 12008: 12010: 22011: 12014: 5, 4 Class I2025: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2009)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BTT

1,743in 2025

2007: 3652008: 4562009: 5582010: 5622011: 6652012: 5832013: 7182014: 7182015: 6702016: 1,0942017: 1,0072018: 9182019: 8942020: 1,1882021: 1,5102022: 7492023: 7162024: 5012025: 1,743
2007high 1,743 (2025) · low 365 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076731365
200841991456
20091—0558
201041132562
201131161665
20122—0583
201361710718
201472315 (4)718
20151—0670
2016315701,094
2017330301,007
20182—0918
20191—0894
20202—01,188
20212—01,510
202232900749
202372580716
202472190501
2025410411,743
202641841—

What is it indicated for?

The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K903138

2 other devices cite the same predicate.

  • K970478SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
  • K962220Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997

Recent decisions in BTT

The BTT category page

  • K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited · 2026
  • K254078HVT 2.0Vapotherm, Inc. · 2026
  • K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited. · 2026
  • K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2026
  • K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K993282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993282: Ipi Humidifier Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993282

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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