510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212045Substantially Equivalent

SoftSpot

Pediametrix Inc, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212045 is the FDA 510(k) clearance record for SoftSpot, a class I device, cleared for Pediametrix, Inc. on under FDA product code QQO (Cranial Measurement Software). FDA's definition for product code QQO reads: "Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods". FDA records list one 510(k) clearance for Pediametrix, Inc. As of , FDA records show no recalls naming K212045.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QQO Cranial Measurement Software
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pediametrix, Inc. 155 Gibbs St., Suite 537, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQO

Trailing 12 months

FDA records hold no clearances under product code QQO in the trailing twelve months.

FDA records show no clearances under product code QQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260