Cleared Traditional

BABYROCKER (K881019) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881019 · Cinventa AB · General Hospital
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Jun 1988
Decision
89d
Days
Class 2
Risk

K881019 is an FDA 510(k) clearance for the BABYROCKER. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Cinventa AB (Sweden, SE). The FDA issued a Cleared decision on June 7, 1988 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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 Cinventa AB devices

Submission Details

510(k) Number K881019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date June 07, 1988
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
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.