510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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A-M Systems

Sequim, WA, US

A-M Systems appears in FDA device records in Sequim, WA. FDA records list 3 510(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
3
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for A-M Systems between 2000 and 2013. The busiest year on record is 2000, with 1. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for A-M Systems, by decision year
YearClearances
20001
20071
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130664HYRDROMAX HMEFCAHSubstantially Equivalent
K063526A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTERCAHSubstantially Equivalent
K000654VBMAXCAHSubstantially Equivalent

Registered establishments

FDA registered establishments for A-M Systems, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30206143020614A-M Systems131 BUSINESS PARK LOOP, Sequim, WA 98382 US2026and 3 more, listed in full below

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-0120-2019Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.Some of the Disposable Smooth Interior Tubing may pull apart when stretched.Class IITerminated
Z-0308-2012ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.Terminated

Verification record

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