510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Single Pass, Inc.

Lake Forest, CA, US

SINGLE PASS, INC. appears in FDA device records in Lake Forest, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Single Pass, Inc. between 2024 and 2026. The busiest year on record is 2024, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Single Pass, Inc., by decision year
YearClearances
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260287SP Electrocautery Device (SP20)GEISubstantially Equivalent
K232805Kronos Electrocautery DeviceGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Single Pass, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30252686893025268689SINGLE PASS, INC.105 North Pointe Drive, Lake Forest, CA 92630 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain