Cleared Traditional

K821310 - ESPREE' ANESTHESIA BACTERIAL FILTER

K821310 is an FDA 510(k) clearance for ESPREE' ANESTHESIA BACTERIAL FILTER, manufactured by Esp Plastics, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K821310 · Esp Plastics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
38d
Days
Class 2
Risk

K821310 is an FDA 510(k) clearance for the ESPREE' ANESTHESIA BACTERIAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Esp Plastics, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Esp Plastics, Inc. devices

FDA 510(k) Submission Details - K821310

510(k) Number K821310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date June 11, 1982
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 157
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K821310.
BREATHING CIRCUIT BACTERIA FILTER
K831856 · Vital Signs, Inc. · Sep 1983
BREATHING FILTER
K830618 · Ohio Medical Products · Apr 1983
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · Ohio Medical Products · Dec 1982
6-435 FILTER PAD, 5/PKG.
K802914 · Lifecare Services, Inc. · Dec 1980
RESPIRGARD
K802763 · Marquest Medical Products, Inc. · Nov 1980
DRYDEN BACTERIA FILTER
K792097 · Dryden Corp. · Nov 1979