# K212045: SoftSpot

- Pathway: 510(k) (Traditional)
- Applicant: Pediametrix, Inc.
- Decided: Sep 28, 2021 after 90 days
- Product code: QQO (Cranial Measurement Software)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Holtain-Kahn Caliper: named in the summary without a submission number

## Indications for use
SoftSpot™ is intended to be used for cranial measurement for infants from 1 month up to 2 years of age in conjunction with other clinical methods. SoftSpot™ is not intended to be used as a tool for preparing a helmet.

Source page: https://510kreport.com/device/K212045
Methodology: https://510kreport.com/methodology