Metrix Co.: FDA filings under this applicant name

FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Metrix Co.” (first 1977, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 236 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
20120—
20130—
20141191
20150—
20160—
20170—
20180—
20190—
20200—
20210—
20220—
20230—
20240—
20250—
20260—

Top product codes

Product codeDeviceSubmissions510(k) clearances
KPEContainer, I.V.22
FPDTube, Feeding11
HGMSystem, Monitoring, Perinatal11
KNTTubes, Gastrointestinal (And Accessories)11
LHISet, I.V. Fluid Transfer11

Review panels

Most recent Metrix Co. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K132424METRIXCAREKNT2014-02-12191
K030888EVA EMPTY SOLUTION CONTAINERKPE2003-04-0212
K895922METRICARE EMPTY CONTAINER SYSTEMSLHI1990-08-22315
K895924METRICARE DRUG RESERVOIRSKPE1990-07-26288
K895923METRICARE ENTERAL FEEDING SYSTEMFPD1990-07-19281
K761201ECHO-CARDIOTRACE, AUTOMATICHGM1977-01-1237

Recalls

33 product recalls in 4 recall events; 16 initiated in the last five years. Most recent: 2024-10-09.

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.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

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 Metrix Co.?

FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Metrix Co.” (first 1977, latest 2014), across 5 product codes in 3 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 Metrix Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Metrix Co. is 236 days.

Which FDA product codes appear under Metrix Co.?

The most frequent FDA product codes under this applicant name are KPE (Container, I.V., 2); FPD (Tube, Feeding, 1); HGM (System, Monitoring, Perinatal, 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 (spelling variants such as punctuation and legal suffixes combined); 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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