Cleared Traditional

K872924 - PARAGON 8500 CARDIO-PULMONARY BED

K872924 is the FDA 510(k) clearance for PARAGON 8500 CARDIO-PULMONARY BED by Surgi-Med, Inc.. It is a Class 2 General Hospital device (product code FNL) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K872924 · Surgi-Med, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
74d
Days
Class 2
Risk

K872924 is an FDA 510(k) clearance for the PARAGON 8500 CARDIO-PULMONARY BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Surgi-Med, Inc. (Lansing, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Surgi-Med, Inc. devices

Submission Details

510(k) Number K872924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date October 09, 1987
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

All 16
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K872924.
CRITICAL CARE HOSPITAL BED (ICU/CCU)
K915437 · Hill-Rom, Inc. · Jun 1992
INVACARE EXTENDED CARE NURSING HOME BED
K900151 · Invacare Corp. · Jun 1990
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · Stryker Corp. · Feb 1988
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
K864172 · Hill-Rom, Inc. · Nov 1986
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
K864186 · Hill-Rom, Inc. · Nov 1986
STRYKER 988 ICU BED
K852674 · Stryker Corp. · Jul 1985