Cleared Traditional

K914994 - HPD HEATER BASES

K914994 is the FDA 510(k) clearance for HPD HEATER BASES by Hpd Medical, Inc.. It is a Class 2 Anesthesiology device (product code BZE) cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K914994 · Hpd Medical, Inc. · Anesthesiology device
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Feb 1993
Decision
463d
Days
Class 2
Risk

K914994 is an FDA 510(k) clearance for the HPD HEATER BASES. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Hpd Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Hpd Medical, Inc. devices

Submission Details

510(k) Number K914994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1991
Decision Date February 12, 1993
Days to Decision 463 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 140d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 14
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K914994.
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · Fisher &Paykel Healthcare , Ltd. · Apr 2012
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · Respironics, Inc. · Jun 2011
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · Fisher &Paykel Healthcare , Ltd. · Jan 2005
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
CONTROLLER, SERVO, INSPIRON
K780630 · C.R. Bard, Inc. · May 1978