Cleared Special

ESPIRT (K001208) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001208 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
28d
Days
Class 2
Risk

K001208 is an FDA 510(k) clearance for the ESPIRT. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 12, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

Submission Details

510(k) Number K001208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2000
Decision Date May 12, 2000
Days to Decision 28 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 73
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K001208.
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993