Cal West Trading Co.: FDA filings under this applicant name

FDA lists 11 510(k) clearances under the applicant name “Cal West Trading Co.” (first 1991, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 70 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
NABGauze / Sponge,Nonresorbable For External Use88
CBPValve, Non-Rebreathing22
EFQGauze/Sponge, Internal11

Review panels

Most recent Cal West Trading Co. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K9503924-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050CBP1995-02-2120
K933756MAGNASHIELD CPR MOUTH BARRIERCBP1994-01-05155
K920269EZ GAUZE SPONGENAB1992-04-2292
K914842GAUZE BANDAGE ROLLNAB1991-12-0437
K912952BANDAGE COMPRESSNAB1991-10-0494
K912950COMPRESS DRESSINGNAB1991-10-0494
K912953GAUZE COMPRESSNAB1991-09-3090
K912955EYE PADEFQ1991-09-1070
K912954STRETCH GAUZE BANDAGENAB1991-09-1070
K91295112-PLY GAUZE PADNAB1991-09-1070

1 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Cal West Trading Co..

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.

Frequently asked questions

How many FDA 510(k) clearances are listed under Cal West Trading Co.?

FDA lists 11 510(k) clearances under the applicant name “Cal West Trading Co.” (first 1991, latest 1995), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Cal West Trading Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Cal West Trading Co. is 70 days.

Which FDA product codes appear under Cal West Trading Co.?

The most frequent FDA product codes under this applicant name are NAB (Gauze / Sponge,Nonresorbable For External Use, 8); CBP (Valve, Non-Rebreathing, 2); EFQ (Gauze/Sponge, Internal, 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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