510(k) Report

FDA applicant

The Master Medical Corp.

San Francisco, CA6 decisions1979–19915 recalls

FDA records 6 decisions for The Master Medical Corp. (San Francisco, CA) from 1979 to 1991: 6 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LDR (Controller, Infusion, Intravascular, Electronic). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided The Master Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Master Medical Corp. since 2007.

Recalls per year

1in 2017

2011: 42017: 1
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Master Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Master Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FPASet, Administration, Intravascular4decisions
  • LDRController, Infusion, Intravascular, Electronic2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K852254I.V. Stat MasterThe Master Medical Corp. · 19851cites it
  • K871753Master Medical Device IS I.V. Stat 2The Master Medical Corp. · 19871cites it

What has FDA decided for it lately?

  • K913076I.V. Instant TimerThe Master Medical Corp. · 1991
  • K905498Stat 2 IV PumpetteThe Master Medical Corp. · 19915 recalls
  • K905497Master Flow I.V. PumpetteThe Master Medical Corp. · 1991
  • K871753Master Medical Device IS I.V. Stat 2The Master Medical Corp. · 1987
  • K852254I.V. Stat MasterThe Master Medical Corp. · 1985
  • K792560Master I.V. Dial LockThe Master Medical Corp. · 1979

All 6 as The Master Medical Corp. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K905498STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets…Jun 19, 2017Class II
  • K905498STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525…Apr 15, 2011
  • K905498STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF…Apr 15, 2011
  • K905498STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length…Apr 15, 2011
  • K905498STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO…Apr 15, 2011

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

Master & Frank Enterprses Co., Ltd. 1Master & Frank Enterprise Co., Ltd. 1Master Hydro Systems, Inc. 1Master Benefits, Inc. 1Master Medical Services, Inc. 1Master & Frank Ent. Co., Ltd. 1