Chrysalis Intelligence · Sponsors · Quest Medical, Inc.

Quest Medical, Inc.

Allen, TX, US · 6 510(k) clearances · 3 recalls

Total clearances
6
2020-06-19 → 2024-12-18
Last 12 months
0
Product codes
2
Most recent
2024-12-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FPA 4 2024-12-18
DTR 2 2020-11-20
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2023-07-14
DateSeverityStatusRecall # ProductCodeReason
2023-07-14 Class II Ongoing Z-0197-2024 Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets … For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous…
2022-12-23 Class II Ongoing Z-1100-2023 Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 Delivery Sets may have tubing that could become detached that could result in patient infection.
2022-12-23 Class II Ongoing Z-1100-2023 Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 Delivery Sets may have tubing that could become detached that could result in patient infection.
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2024-12-18 K241058 Lyka® PORT Needle Free Access Device (4170Y) FPA
2022-06-05 K213846 Q2 Blood Administration Sets FPA
2022-06-02 K213588 Q2 IV Administration Sets FPA
2021-01-21 K202672 Precision Delivery Infusion Set FPA
2020-11-20 K201984 MPS 3 ND Myocardial Protection System DTR
2020-06-19 K200438 MPS 3 Myocardial Protection System DTR