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BlastGen

by Origio A/S

510(k) K152932

BlastGen is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K152932 on 29 Feb 2016, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152932 Date29 Feb 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQL
Device class
Class II
Regulation
21 CFR Part 884.6180
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K152932

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K152932
UDI-DISize and differences
BlastGen 12050003D
Origio A/S
12050003D00888937801477 —On the market
BlastGen 12050003M
CooperSurgical, Inc.
12050003M00888937029475 —On the market
EmbryoGen & BlastGen 12062003D
Origio A/S
12062003D60888937819832 —On the market
EmbryoGen & BlastGen 12062003M
CooperSurgical, Inc.
12062003M60888937029484 —On the market

Similar devices

Other devices filed under FDA product code MQL (Media, Reproductive).

Other devices from Origio A/S

See all devices from Origio A/S →