Conception Technologies: FDA filings under this applicant name

FDA lists 8 510(k) clearances under the applicant name “Conception Technologies” (first 2000, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 42 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
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Top product codes

Product codeDeviceSubmissions510(k) clearances
MQLMedia, Reproductive77
MTWSystem, Water, Reproduction, Assisted, And Purification11

Review panels

Most recent Conception Technologies 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K030850ENHANCE HUMAN SERUM ALBUMINMQL2003-04-0822
K023717SPERM WASH MEDIUM WITH GENTAMICINMQL2002-12-1338
K023655ENHANCE HTF MEDIUM WITH HEPESMQL2002-12-1344
K020490PBS, PBSW WITH CATIONS AND PHENOL REDMQL2002-03-2843
K011573HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUMMQL2001-07-0242
K01148110% PVP; 10% PVP IN EBSS SOLUTIONMQL2001-07-0249
K011462OIL FOR TISSUE CULTUREMQL2001-06-1330
K993140WATER FOR TISSUE CULTURE, MODELS 1500MTW2000-08-02317

Recalls

openFDA lists no recalls under a recalling firm named Conception Technologies.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Conception Technologies?

FDA lists 8 510(k) clearances under the applicant name “Conception Technologies” (first 2000, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Conception Technologies?

The median time from FDA receipt to decision across 510(k)s cleared under the name Conception Technologies is 42 days.

Which FDA product codes appear under Conception Technologies?

The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 7); MTW (System, Water, Reproduction, Assisted, And Purification, 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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