Sscor: FDA filings under this applicant name

FDA lists 5 510(k) clearances under the applicant name “Sscor” (first 1994, latest 2004), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 17 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
BTAPump, Portable, Aspiration (Manual Or Powered)44
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered11

Review panels

Most recent Sscor 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K041154S-SCORT...JR QUICKDRAW, MODEL 2400BTA2004-05-1815
K964997S-SCORT (2500)BTA1997-03-0579
K952632S-SCORTBTA1995-06-168
K950464SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLESGCX1995-04-2581
K945929S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMPBTA1994-12-2217

Recalls

openFDA lists no recalls under a recalling firm named Sscor.

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 Sscor?

FDA lists 5 510(k) clearances under the applicant name “Sscor” (first 1994, latest 2004), across 2 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 Sscor?

The median time from FDA receipt to decision across 510(k)s cleared under the name Sscor is 17 days.

Which FDA product codes appear under Sscor?

The most frequent FDA product codes under this applicant name are BTA (Pump, Portable, Aspiration (Manual Or Powered), 4); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 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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