510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Precision Medical Products

Rocklin, CA, US

Precision Medical Products appears in FDA device records in Rocklin, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Precision Medical Products carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Ortho8, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Precision Medical Products between 2001 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Precision Medical Products, by decision year
YearClearances
20011
20031
20212
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220761CIRCUL8 Connect DVT Prevention DeviceJOWSubstantially Equivalent
K212731Circul8 ProJOWSubstantially Equivalent
K211235CIRCUL8 Luxe DVT Prevention DeviceJOWSubstantially Equivalent
K031630BIFURCATED ALLERGY SKIN TESTING NEEDLESCLSubstantially Equivalent
K012515BIFURCATED VACCINATING NEEDLESCLSubstantially Equivalent

Registered establishments

FDA registered establishments for Precision Medical Products, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30160009733016000973Precision Medical Products3735 Cincinnati Ave Ste 100, Rocklin, CA 95765 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2325-2021EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not SterileEVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearanceClass IIOpen, Classified
Z-2324-2021CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearanceClass IIOpen, Classified

Verification record

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